Swissmedic Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Swissmedic (Swiss Agency for Therapeutic Products)
Key Legislation:
- Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA/HMG)
- Medical Devices Ordinance (MedDO) -- effective 26 May 2021, aligned with EU MDR 2017/745
- Ordinance on In Vitro Diagnostic Medical Devices (IvDO) -- effective 26 May 2022, aligned with EU IVDR 2017/746
Classification: Risk-based, 4 classes (I, IIa, IIb, III) -- mirroring the EU MDR classification system.
Registration Pathway:
- Conformity assessment under EU MDR with an EU Notified Body (CE marking required)
- Appoint a Swiss Authorised Representative (CH-REP) for foreign manufacturers
- Register as economic operator in swissdamed to obtain CHRN (Swiss Registration Number)
- Register devices in swissdamed UDI Devices module (mandatory from 1 July 2026)
Key Requirements:
- CE marking under EU MDR/IVDR is required for Swiss market access
- CH-REP is mandatory for all non-Swiss manufacturers (EU AR does not satisfy this requirement)
- swissdamed device registration: mandatory from 1 July 2026, transition period until 31 December 2026
- No interface between swissdamed and EUDAMED -- separate registration required
Current Key Guidance:
- swissdamed Registration Guide
- CH-REP & Economic Operator Registration (CHRN)
- FSCA Reporting (Vigilance)
Latest Updates
IV Sets or Administration Sets - ICU Medical, Inc.
2026-08-13 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: IV Sets or Administration Sets. Reason: . Model: various.
SPECTRALIS with FLex Module - Heidelberg Engineering GmbH
2026-08-12 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Ophthalmology instruments. Reason: . Model: .
Swissmedic FSCA: Alber e-motion M25 Wheelchair Propulsion System – Added Language
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic FSCA covers the e-motion M25 wheelchair electric-motor-driven propulsion system from Alber GmbH. The corrective action was issued because a new language has been added to the device documentation/labeling. The affected model is M25. Responsible parties should update and distribute the new language version according to Swissmedic requirements.
Tags: swissmedic_fsca, labeling_update, wheelchair_propulsion
Bravo CF capsule delivery dev - Given Imaging Inc.
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Gastrointestinal telemetric monitoring system. Reason: additional languages added. Model: FGS-0635, FGS-0636.
EPIQ Ultrasound System - Philips Medical Systems Nederland B.V.
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: General-purpose ultrasound imaging system. Reason: . Model: 795234.
Healon Duet - AMO Uppsala AB
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Ophthalmology, hyaluronic acid and derivatives. Reason: . Model: 10301016.
Swissmedic FSCA: Healon EndoCoat by AMO Uppsala AB, Model 10301012
2026-08-11 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for Healon EndoCoat, manufactured by AMO Uppsala AB, an intraoperative vitreous/aqueous humour replacement medium, covering model 10301012. The specific reason for the corrective action is not detailed in the brief alert summary; regulatory affairs professionals should review the full Swissmedic FSCA notice for detailed reason and required actions. Users with affected product should verify inventory and follow the manufacturer’s field safety notice.
Tags: swissmedic, fsca, ophthalmic_device
Swissmedic FSCA: Edwards Lifesciences ForeSight Oximeter Cable for Bedside Monitors
2026-08-11 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a field safety corrective action (FSCA) concerning the Edwards Lifesciences ForeSight Oximeter Cable, which is used with general-purpose multi-parameter bedside monitors. The specific reason and affected model/lot are referenced in the manufacturer’s Field Safety Notice (FSN). Users should review the FSN and follow the manufacturer’s recommended corrective actions.
Tags: swissmedic, fsca, medical_device, oximeter_cable, field_safety_corrective_action
Philips Azurion Angiographic X-Ray System: Swissmedic FSCA for Multiple Models
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action (FSCA) concerns the Philips Azurion stationary angiographic X-ray system, manufactured by Philips Medical Systems Nederland B.V. The affected models include 722063, 722064, 722067, 722068, 722078, 722079, 722221 through 722228, and 722280. The provided notice does not specify the reason for the corrective action, so regulatory affairs professionals and affected users should consult the official Swissmedic FSCA and Philips instructions for required actions.
Tags: swissmedic, fsca, medical_device_safety
Swissmedic FSCA: ORBIS Medication 3.x – DH Healthcare GmbH
2026-08-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for ORBIS Medication 3.x, a medical device software from DH Healthcare GmbH. The action addresses a potential safety issue related to medication management. Affected users should consult the manufacturer’s notice for required measures, which may include software updates or workarounds, to ensure safe use.
Tags: swissmedic, fsca, medical_device_software, medication_safety, dh_healthcare
Swissmedic FSCA: GXD5 PACS by ENOVACOM – Field Safety Corrective Action for PACS
2026-08-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the GXD5 Picture Archiving and Communication System (PACS) from ENOVACOM. The specific reason for the corrective action and affected models were not provided in the notification. Users of this device should check the official Swissmedic FSCA page and contact the manufacturer for detailed instructions and required actions.
Tags: swissmedic, fsca, pacs, medical_device, safety_notice
Field Safety Corrective Action for medin Medical Innovations NC3 Neonatal CPAP Unit
2026-08-07 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the medin Medical Innovations GmbH neonatal CPAP unit, models NC3 and 3000. The action addresses a potential safety issue with the device. Healthcare facilities using these models should immediately follow the manufacturer's corrective instructions to mitigate risks and ensure continued safe use.
Tags: fsca, neonatal_cpap, swissmedic, field_safety_corrective_action, medin_medical_innovations, nc3, 3000, patient_safety
Swissmedic FSCA for Cardioroot Woven Synthetic Vascular Graft by Intervascular SAS
2026-08-06 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Cardioroot Woven, a non-medicated synthetic vascular graft manufactured by Intervascular SAS. The specific reason for the corrective action was not detailed in the public notice. Affected model numbers include HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, and HEWROOT0034. Users should immediately consult the manufacturer’s FSCA notice and follow all recommended actions to ensure patient safety.
Tags: swissmedic, fsca, vascular_graft, intervascular, cardioroot_woven, medical_device_safety
Swissmedic FSCA: Hemospray Endoscopic Hemostat (Cook Endoscopy) Models HEMO-7, HEMO-10
2026-08-05 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for Cook Endoscopy’s Hemospray Endoscopic Hemostat, affecting models HEMO-7 and HEMO-10. The notice covers a non-organic haemostatic agent; the specific reason for the action was not detailed in the FSCA. Affected users should immediately follow the manufacturer’s instructions, which likely include quarantine and return of the devices.
Tags: fsca, endoscopic_hemostat, cook_endoscopy
FSCA for ALPHAMAQUET Electrohydraulic Operating Table Base by MAQUET GmbH (Models 115002B0)
2026-08-05 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the ALPHAMAQUET electrohydraulic operating table base, manufactured by MAQUET GmbH. The affected model is listed as 115002B0 (appears twice). The reason for the corrective action is not specified in the notice, but users are advised to consult the manufacturer's instructions and the FSCA portal for recommended actions. This is a safety-related alert for healthcare facilities using this operating table base.
Tags: fsca, operating_table, swissmedic, maquet, safety_alert
Swissmedic FSCA: MAQUET Electrohydraulic Operating Table Base Model 115002D0
2026-08-05 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for MAQUET GmbH's electrohydraulic operating table base, model 115002D0. The specific safety issue has not been publicly detailed, but affected users must immediately implement the manufacturer's corrective measures to mitigate risk.
Tags: swissmedic, fsca, operating_table, maquet, medical_device
ALPHAMAQUET Operating table column - MAQUET GmbH
2026-08-05 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Electrohydraulic operating table base. Reason: . Model: 115002A0; 115002A0.
Swissmedic FSCA: MAQUET Mobile OR-Table Column (Model 115002C0)
2026-08-05 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for the MAQUET GmbH mobile electrohydraulic operating table column, model 115002C0. The corrective action addresses a safety issue with the table base. Affected users should immediately follow the manufacturer’s instructions in the FSCA notice and contact MAQUET for further guidance.
Tags: swissmedic, fsca, maquet, operating_table, safety_correction, medical_device
Swissmedic FSCA for Maquet Cardiopulmonary Vascular Catheter Introduction Set, Model 701047385
2026-08-04 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the non-implantable vascular catheter introduction set manufactured by Maquet Cardiopulmonary GmbH, specifically model 701047385. The public notice does not detail the reason for the corrective action. Healthcare facilities and professionals should identify affected units and follow the manufacturer's safety instructions without delay.
Tags: swissmedic_fsca, vascular_catheter, maquet_cardiopulmonary, field_safety_corrective_action
Swissmedic FSCA: Maquet Cardiopulmonary GmbH PIK 100-USA Vascular Catheter Introduction Set (Model 701053068)
2026-08-04 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the PIK 100-USA vascular catheter introduction set, manufactured by Maquet Cardiopulmonary GmbH, affecting model 701053068. The specific reason for the corrective action was not detailed in the initial notice. Users should identify any affected devices in their inventory and follow the manufacturer's instructions for corrective measures.
Tags: fsca, swissmedic, vascular_catheter, maquet, corrective_action
PIK 100 Vascular Catheter Introduction Set: Swissmedic Field Safety Corrective Action
2026-08-04 | Swissmedic | Safety Communication | !!! HIGH
Maquet Cardiopulmonary GmbH has issued a Field Safety Corrective Action (FSCA) for the nonimplantable vascular catheter introduction set model PIK 100 (model 701047384). The specific reason for the corrective action has not been detailed in the Swissmedic notification. Affected users should immediately follow the manufacturer’s instructions and contact Maquet Cardiopulmonary GmbH for necessary guidance and remedial steps.
Tags: swissmedic, fsca, medical_device, catheter_introduction_set, maquet
Swissmedic Issues FSCA for Maquet PIK Dilator Set L (Model 701054427)
2026-08-04 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic published a Field Safety Corrective Action (FSCA) from Maquet Cardiopulmonary GmbH for the PIK dilator set L, a nonimplantable vascular catheter introduction set, model 701054427. The specific reason for the corrective action was not detailed in the notice. Users should consult the manufacturer's communication for required actions to mitigate any potential risk associated with the device.
Tags: swissmedic, fsca, maquet_cardiopulmonary, vascular_catheter_introduction_set, pik_dilator_set
Swissmedic FSCA: PIK dilator S (Model 701054606) by Maquet Cardiopulmonary GmbH
2026-08-04 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the PIK dilator S (model 701054606), a non-implantable vascular catheter introduction set manufactured by Maquet Cardiopulmonary GmbH. The specific reason for the action has not been detailed in the public notice, but affected users should immediately identify and quarantine the device and follow the manufacturer's instructions for corrective measures. This alert applies to the specified model number.
Tags: fsca, vascular_catheter, maquet_cardiopulmonary, swissmedic, device_safety
PIK 150-USA - Maquet Cardiopulmonary GmbH
2026-08-04 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Vascular catheter introduction set, nonimplantable. Reason: . Model: 701053069.
Swissmedic FSCA: MED-STOP Devices in Soft Liner Suction Canister Kits – GMDN Code Correction (Medline Industries LP)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action addresses MED-STOP devices included in Medline Industries LP's Soft Liner Suction Canister Kits (models OR53916, OR53926, OR53929, OR54916, OR54926). The correction is due to the Global Medical Device Nomenclature (GMDN) code originally being assigned to the kit rather than the MED-STOP component, which may cause misidentification. Medline is updating the GMDN designation accordingly; users should verify their records reflect the correct nomenclature for the MED-STOP device.
Tags: swissmedic, fsca, gmdn, suction_canister, medline, labeling_correction
Swissmedic Issues Field Safety Corrective Action for Mindray BeneHeart D1 Automated External Defibrillator
2026-07-31 | Swissmedic | Safety Communication | !!! HIGH
The Swiss Agency for Therapeutic Products (Swissmedic) has published a Field Safety Corrective Action (FSCA) for the BeneHeart D1 Automated External Defibrillator manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The specific reason for the correction is not detailed in the brief notice, but the device is classified as a physiologic-monitoring defibrillation system. Affected model is the BeneHeart D1. Healthcare facilities and users should immediately refer to the manufacturer's instructions for the corrective measures and monitor the official Swissmedic notice for further details.
Tags: swissmedic, fsca, defibrillator, mindray, recall
Swissmedic FSCA: Mindray iPM Patient Monitors (Models 5, 6, 7, 8, 10, 12, 9800)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for the Mindray iPM Series Patient Monitor. Affected models include 5, 6, 7, 8, 10, 12, and 9800. The reason involves a safety-related issue; users must follow the manufacturer’s corrective instructions to mitigate risks.
Tags: swissmedic, fsca, patient_monitor, mindray, product_correction
Swissmedic FSCA: Mindray TMS40/TMS-6016/TM80 Telemetry Monitors Subject to Field Safety Corrective Action
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Mindray general-purpose multi-parameter bedside telemetry monitors, models TMS40, TMS-6016, and TM80. The specific reason for the corrective action was not detailed in the alert, but users should be aware of potential safety-related concerns. Affected facilities should immediately check their inventory for these models and follow the manufacturer's instructions as communicated by Mindray. Swissmedic advises verifying device compliance and implementing any required corrective measures to maintain patient safety.
Tags: telemetry_monitor, mindray, fsca, swissmedic, field_safety_corrective_action, medical_device
Swissmedic Issues FSCA for Mindray uMEC Series Patient Monitors
2026-07-31 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the uMEC Series bedside multi-parameter patient monitors manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The corrective action addresses a potential safety issue that could affect device performance (specific reason not detailed in the public summary). Affected models include uMEC 6, 7, 10, 12, 15, 15S, 30, 60, 70, 80, 100, 120, and 150. Healthcare facilities should immediately follow the manufacturer's instructions provided in the FSCA notification and contact Mindray for necessary corrective steps.
Tags: swissmedic, fsca, patient_monitor, mindray, safety_alert
Swissmedic FSCA: iMEC Series Patient Monitor by Shenzhen Mindray – Reason Not Disclosed
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the iMEC Series Patient Monitor, a general-purpose multi-parameter bedside monitor manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The specific reason for the corrective action and the affected models/lots were not provided in the notice. Healthcare facilities using this device should monitor official channels for further details and follow any instructions from the manufacturer.
Tags: fsca, swissmedic, patient_monitor, mindray, safety_corrective_action
Swissmedic FSCA for Mindray BeneHeart Defibrillator/Monitor Systems (Models D20, D30, D50, D60, D2, D3, D5, D6 and variants)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a Field Safety Corrective Action for Shenzhen Mindray Bio-Medical Electronics' BeneHeart physiologic-monitoring defibrillation systems. Affected models include D20, D20A, D20C, D30, D50, D50A, D50C, D60, DX, DM, D2, D3, D5, and D6. The manufacturer is implementing a correction; users should consult the FSCA notice for required actions. No specific recall reason was detailed in the notification.
Tags: switzerland, fsca, defibrillator, mindray, field_safety_corrective_action
Swissmedic FSCA for Mindray BeneView T Series Patient Monitors (Models T1/T5/T5S/T5 OR/T6/T8/T9/T9 OR)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
The Swiss Agency for Therapeutic Products (Swissmedic) issued a Field Safety Corrective Action (FSCA) for Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s BeneView T Series multi-parameter bedside monitors. Affected models include T1, T5, T5S, T5 OR, T6, T8, T9, and T9 OR. While the specific safety reason was not disclosed in the public notice, healthcare facilities using these devices should immediately consult Mindray or their local representative for the recommended corrective actions, which may involve inspection, software updates, or part replacement.
Tags: swissmedic, fsca, patient_monitor, mindray, safety_corrective_action
Swissmedic Issues FSCA for Mindray Benevision V Series Patient Monitor
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for the Benevision V Series patient monitor from Shenzhen Mindray Bio-Medical Electronics. The notice (reference Vk_20260727_033) relates to the general-purpose multi-parameter bedside monitor; however, the specific safety reason and affected model/lot details were not included in the initial alert. Users should consult the full FSCA on the Swissmedic website to identify impacted devices and take recommended corrective actions.
Tags: swissmedic, fsca, patient_monitor, mindray, safety_corrective_action
Swissmedic FSCA: Mindray Benevision N1 Patient Monitor Field Safety Corrective Action
2026-07-31 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Mindray Benevision N1 general-purpose multi-parameter bedside monitor. The notice did not specify the reason or affected model numbers, but typical actions involve a safety-related correction. Healthcare facilities using this device should consult the full FSCA on Swissmedic's platform and follow the manufacturer's instructions.
Tags: fsca, swissmedic, patient_monitor, mindray, safety_corrective_action
Swissmedic FSCA: Renishaw Mayfield’s neuromate Stereotactic System, Model 001.0050 – Reason Not Detailed
2026-07-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the neuromate neurological stereotactic surgery system manufactured by Renishaw Mayfield SARL. The affected model is 001.0050. The official notice did not include the specific reason for the corrective action; users should monitor manufacturer communications for instructions.
Tags: swissmedic, fsca, stereotactic_system, neurosurgery, renishaw_mayfield
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis - W L Gore & Associates Inc
2026-07-29 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Ptfe vascular endoprostheses, straight - other. Reason: . Model: all; all.
FSCA: ORBIS Medication 3.x software by DH Healthcare GmbH may cause medication errors
2026-07-29 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action for ORBIS Medication 3.x, a medical device software for medication management by DH Healthcare GmbH. The corrective action addresses a potential defect that could lead to incorrect medication dosage display or administration, posing risks to patient safety. Affected users should immediately verify medication orders and apply the manufacturer's update to mitigate the risk.
Tags: software_recall, medication_error, swissmedic_fsca, field_safety_corrective_action, medical_device_software
ConvaTec Esteem Body Ostomy Pouches: Swissmedic FSCA for Labeling Content Correction
2026-07-28 | Swissmedic | Safety Communication | !! MEDIUM
ConvaTec issued a Field Safety Corrective Action for the Esteem Body 1 Piece Soft Convex Ostomy Pouches (one-piece urostomy bag, open-ended) in Switzerland. The correction updates the English and German versions of the document to fix the distribution date in English, and in German, to include information from the customer care team on product alternatives and to correct a table header. Affected models are listed in the Field Safety Notice; users should ensure they have the updated documentation. This is a medium-priority labeling correction.
Tags: swissmedic, fsca, labeling_correction
Swissmedic FSCA: Ethicon Gynecare TVT (Model TVTRL) for Incontinence – Field Safety Corrective Action
2026-07-27 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for the Gynecare TVT device, manufactured by Ethicon SARL. The affected model is TVTRL, described as an incontinence clamp. The specific reason for the correction was not publicly detailed, but users are advised to follow the manufacturer's instructions provided in the FSCA notification to ensure patient safety.
Tags: fsca, swissmedic, incontinence_device, ethicon, gynecare_tvt, field_safety_corrective_action
Swissmedic FSCA for Philips Azurion Stationary Angiographic X-Ray Systems
2026-07-24 | Swissmedic | Safety Communication | !! MEDIUM
Philips Medical Systems Nederland B.V. has issued a Field Safety Corrective Action (FSCA) for specific models of its Azurion stationary angiographic x-ray systems. The affected models include 722063, 722064, 722067, 722068, 722078, 722079, and a series from 722221 to 722236, 722280 to 722282. The corrective action addresses a potential safety issue, though details are not publicly specified in the notice. Users of these systems should promptly contact Philips or refer to the manufacturer’s instructions for the required corrective measures.
Tags: swissmedic, fsca, angiographic_xray
Swissmedic FSCA for Introducer Kit for Impella by Abiomed/Oscor
2026-07-23 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action (FSCA) for the vascular catheter introduction set (Introducer Kit for Impella) manufactured by Abiomed Inc. with Oscor. Affected models include 0052-3046, 0052-3052, 0052-3053, 0052-3006, 0052-3021 and catalogue numbers 0048-0014, 0052-0038, 0052-0039, 1000482, 0052-0011-EU, 0550-0002, 0046-0011, 0052-0002-EU. Users should immediately check inventory, quarantine the affected devices, and follow the manufacturer's instructions for correction.
Tags: swissmedic, fsca, impella, introducer_kit, vascular_catheter, abiomed
Swissmedic FSCA: BD neXus Disposable Infusion Set by MEDCAPTAIN – Safety Correction
2026-07-22 | Swissmedic | Safety Communication | !! MEDIUM
A field safety corrective action has been issued for the BD neXus Disposable Infusion Set, an electric infusion pump administration set for single use, manufactured by MEDCAPTAIN LIFE SCIENCE CO., LTD. Affected models include A211M, A211M1F, A211M5F1, A311M, A311M021F, and A212M1F. The specific reason was not detailed in the initial notice, but users are advised to follow manufacturer instructions, typically involving quarantine and return of affected devices. Further details are available on the Swissmedic FSCA portal.
Tags: fsca, infusion_set, swissmedic, medical_device_safety, medcaptain
Swissmedic Issues Field Safety Corrective Action for Pride Mobility Q6 Edge Electric Wheelchairs
2026-07-22 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Pride Mobility's Q6 Edge 4, Q6 Edge 3 Stretto, and Q6 Edge 3 electric-motor-driven wheelchairs. The action addresses a potential safety concern that could affect occupant-controlled operation. Affected users and healthcare professionals should follow the manufacturer's Field Safety Notice for inspection or correction, and contact Pride Mobility or their supplier for specific instructions.
Tags: swissmedic, fsca, electric_wheelchair, pride_mobility, safety_corrective_action, mobility_aid
Swissmedic FSCA for Straumann BLT Ø4.1mm RC SLActive® 12mm TiZr Dental Implant (Model 021.5312)
2026-07-22 | Swissmedic | Safety Communication | !! MEDIUM
Institut Straumann AG has issued a Field Safety Corrective Action (FSCA) for its BLT Ø4.1mm RC, SLActive® 12mm, TiZr, NTP dental implant (model 021.5312). The Swissmedic notice does not specify the reason for the correction, but distributors and healthcare professionals must follow recommended actions. Affected parties should consult the official FSCA for instructions, which may involve quarantine, return, or enhanced monitoring.
Tags: fsca, swissmedic, dental_implant, straumann
Swissmedic Issues FSCA for Permobil M5 Corpus Electric Wheelchair (Model M5)
2026-07-22 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the Permobil M5 Corpus electric-motor-driven wheelchair, manufactured by Permobil AB. The specific reason for the corrective action was not detailed in the notice, but the notice targets the M5 model. Affected users and healthcare providers should follow the manufacturer's recommendations and contact Permobil AB for further instructions.
Tags: swissmedic, fsca, permobil, electric_wheelchair, m5_corpus, safety_corrective_action
Swissmedic FSCA: UroDapter Sterile Single-Use Urological Adapter by Pharmico Medical Kft.
2026-07-22 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for UroDapter, a sterile single-use urological adapter from Pharmico Medical Kft. Affected models include date-coded lots 20230228, 20230929, 20240430, 20241031, 20251231, 20260130, and 20260430. While the specific reason is not publicly detailed, healthcare facilities should quarantine affected units and follow the manufacturer's corrective instructions. The notice appears on the Swissmedic FSCA portal.
Tags: swissmedic, fsca, medical_device, urology, sterile_adapter, field_safety_corrective_action, pharmico_medical
Swissmedic FSCA: IALUADAPTER Sterile Urological Adapter by Pharmico Medical Kft.
2026-07-22 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action for the IALUADAPTER, a sterile single-use urological adapter from Pharmico Medical Kft. The reason for the corrective action was not specified in the notice, but affected models include 2300023, 2300070, 2400068, 2400133, 2500119, 2500134, and 2600044. Users should immediately quarantine the listed devices and follow the manufacturer's instructions for return or disposal.
Tags: field_safety_corrective_action, urological_device, swissmedic, recall, pharmico_medical
FSCA Update: Stryker Hoffmann II Micro Connecting Rods - Response Deadline Change
2026-07-21 | Swissmedic | Safety Communication | !! MEDIUM
Stryker GmbH has issued a Field Safety Corrective Action (FSCA) for its Hoffmann II Micro connecting rods, part of external bone fixation systems. The sole purpose of this action is to update the response deadline for previously communicated corrective measures. Affected model numbers are 50796030, 50796040, 50796050, 50796060, 50796090, 50796120, and 50796150. Users should note the revised deadline and ensure their responses are submitted accordingly.
Tags: swissmedic, fsca, stryker, external_fixation, hoffmann_ii_micro, deadline_update
Swissmedic FSCA: Medtronic Sphere-360 Catheter (AFR-00012) – Language Addition Correction
2026-07-21 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Medtronic Sphere-360 cardiac ablation catheter (model AFR-00012) due to an added language in its labeling. This is a product correction, not a recall, requiring no product return. Healthcare facilities and distributors should ensure the updated labeling is in place and continue using the device safely.
Tags: fsca, medtronic, labeling_update
Swissmedic Issues FSCA for MEDICO TECHNOLOGIES Sterile Single Use Tear Duct Cannula (S-140097, S-140096)
2026-07-21 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Sterile Single Use Tear Duct Cannula manufactured by MEDICO TECHNOLOGIES, affecting models S-140097 and S-140096. The specific reason for the corrective action was not detailed in the public notice, though it pertains to lacrimal duct devices. Healthcare facilities are advised to immediately identify and quarantine affected units and follow the manufacturer's instructions for return or correction.
Tags: swissmedic, fsca, medical_device_recall, lacrimal_cannula, medico_technologies
Swissmedic FSCA for Aesculap AG Silver Graft (Helix) Vascular Prosthesis – Model Info in FSN
2026-07-21 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Silver Graft (Helix) Vascular Prosthesis, a synthetic non-medicated graft from Aesculap AG. The specific reason for the action is not detailed in the public notice; affected model and lot numbers are provided in the manufacturer's Field Safety Notice (FSN). Healthcare providers should immediately identify impacted devices, consult the FSN, and follow recommended actions, which typically include quarantine and return.
Tags: swissmedic, fsca, vascular_prosthesis, aesculap_ag, implant, field_safety_corrective_action
Swissmedic FSCA: Philips Cardiac Workstation 7000 Electrocardiograph, Model 860441 (Reason Not Specified)
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Philips Medizin Systeme Böblingen GmbH Cardiac Workstation 7000, a professional multichannel electrocardiograph, model 860441. The specific reason for the corrective action was not detailed in the public notice. Users should contact Philips or their local representative for the necessary corrective measures, which may involve a software update, hardware inspection, or other risk mitigation steps to ensure device safety and performance.
Tags: switzerland, fsca, electrocardiograph, philips, safety_corrective_action, medical_device
Philips Cardiac Workstation 5000 (Model 860439) Swissmedic Field Safety Corrective Action
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Philips Medizin Systeme Böblingen GmbH has issued a Field Safety Corrective Action (FSCA) for the Cardiac Workstation 5000, a professional multichannel electrocardiograph. The affected model is 860439. While the specific reason was not detailed in the Swissmedic notice, users should contact Philips or follow the manufacturer's instructions for required actions. This FSCA is registered under Swissmedic reference Vk_20260702_031.
Tags: fsca, swissmedic, electrocardiograph, philips, medical_device, field_safety_corrective_action
Swissmedic FSCA for Covidien BOX BYPASS KIT (Model BOX09222V1) – December 2025 Action
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for the BOX BYPASS KIT, model BOX09222V1, manufactured by Covidien llc. The notice, dated December 2025, alerts users to a safety-related issue requiring corrective measures. Affected healthcare facilities should immediately review the manufacturer's instructions, which may involve product inspection, quarantine, or return. Detailed rationale and required actions are provided in the full FSCA, accessible via Swissmedic's portal.
Tags: swissmedic, fsca, covidien, box_bypass_kit, safety_corrective_action
Swissmedic FSCA: Covidien V-Loc 180 Bioabsorbable Sutures – Models VLOCL0024, VLOCL0306, and Others
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for specified models of the V-Loc 180 polyester, bioabsorbable, monofilament, non-antimicrobial suture manufactured by Covidien llc. The affected model numbers are VLOCL0024, VLOCL0306, VLOCL0316, VLOCL0604, VLOCL0644, VLOCL0804, VLOCL2105, VLOCL2145, and VLOCL2246. While the notice does not detail the specific reason, healthcare facilities should identify and quarantine the affected products and follow the manufacturer's instructions to prevent potential patient risk.
Tags: swissmedic, fsca, covidien, v_loc_180, suture, recall
Swissmedic FSCA: V-Loc 90 Barbed Suture by Covidien llc (Models VLOCM0003, VLOCM0013, VLOCM0604)
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for V-Loc 90, a barbed polyester suture manufactured by Covidien llc. The affected models are VLOCM0003, VLOCM0013, and VLOCM0604. While the specific reason was not detailed in the notice, healthcare facilities should identify and quarantine affected lots, and follow the manufacturer's instructions for return or correction.
Tags: barbed_suture, field_safety_corrective_action, swissmedic, covidien
Swissmedic FSCA on Medtronic MiniMed 640G Insulin Pump Models MMT-1711, MMT-1712
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Medtronic MiniMed 640G ambulatory insulin infusion pumps, covering electronic pump models MMT-1711 and MMT-1712. The reason for the corrective action is not publicly detailed in the notification. Users and healthcare professionals should follow the manufacturer's immediate recommendations and contact Medtronic for further instructions.
Tags: fsca, swissmedic, insulin_pump, medtronic, corrective_action, safety
Swissmedic FSCA: Medtronic MiniMed 670G Insulin Pump – Software-Dosing Scalar Algorithm Correction
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for the Medtronic MiniMed 670G ambulatory insulin infusion pump (models MMT-1781, MMT-1782) due to a potential issue in the software-dosing scalar algorithm. Healthcare professionals and patients using the affected devices should immediately consult the manufacturer’s instructions to mitigate any insulin delivery risk. Medtronic is expected to provide a software correction or other remedial actions.
Tags: swissmedic, fsca, insulin_pump, software_correction, medtronic, recall
Swissmedic FSCA: Medtronic MiniMed 780G Insulin Pump Software-Dosing Algorithm Correction
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action for the Medtronic MiniMed 780G ambulatory insulin infusion pump (models MMT-1885CLW and MMT-1886CLW) due to a potential issue with its electronic software-dosing scalar algorithm. The corrective action aims to mitigate risks associated with the affected software. Users and healthcare providers are advised to contact Medtronic for the recommended corrective steps, which may include software updates or device inspection.
Tags: swissmedic, fsca, insulin_pump, medtronic, software_correction, medical_device_safety
Swissmedic FSCA: Hollister Onli & Infyna Hydrophilic Intermittent Catheters – Safety Correction
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for specific models of Hollister Incorporated's Onli and Infyna hydrophilic urethral intermittent catheters. The action affects multiple catalog numbers including 82081, 82121, 88081, 82084, 85124, and others listed in the notice. Affected devices are single-administration urethral drainage catheters, and users should immediately follow the manufacturer's instructions provided in the field safety notice. No specific reason is publicly detailed, but the corrective action indicates a potential risk requiring risk mitigation measures.
Tags: fsca, swissmedic, catheter_recall, hollister, urology_device
Swissmedic FSCA: Shimadzu Diagnostic X-ray System Generators UD150B-40/UD150V-40/UD150L-40/UD150L-40E/F
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Shimadzu stationary diagnostic X-ray system generators, models UD150B-40, UD150V-40, UD150L-40, and UD150L-40E/F. The notice does not specify the reason for the corrective action. Affected users should refer to Swissmedic case number Vk_20260713_052 for required actions.
Tags: fsca, swissmedic, x-ray, diagnostic_imaging, shimadzu, medical_device_correction
Swissmedic FSCA: Kröber O2 Oxygen Concentrator – Correction of Duplicate Model/Catalog Numbers
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for Kröber O2 oxygen concentrators (models KRO2.00, KR4.00) because duplicate entries in model and catalog numbers have been corrected. This is a documentation correction and does not involve a product recall. Affected users and distributors should refer to the updated manufacturer information to ensure correct identification of the devices.
Tags: swissmedic, fsca, oxygen_concentrator, kroeber, model_correction
Swissmedic FSCA: Schiller AG SEMA Clinical Data Interfacing Software (Models 0A.602010, 0A.602030, 0A.602000, 0A.602020)
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Schiller AG's SEMA medical equipment clinical data interfacing software. The affected models are 0A.602010, 0A.602030, 0A.602000, and 0A.602020. While the specific reason for the corrective action was not detailed in the public notice, users should review the FSCA documentation and follow any manufacturer or Swissmedic recommendations.
Tags: medical_device, fsca, swissmedic, software, clinical_data, schiller, product_correction
Swissmedic FSCA: Boston Scientific OverStitch Suture Cinch Models M00505530 and M00505540
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
The Swiss Agency for Therapeutic Products (Swissmedic) issued a Field Safety Corrective Action for the OverStitch Suture Cinch, a single-use suture/ligature tightener manufactured by Boston Scientific Corporation. The affected models are M00505530 (GTIN: 00191506060046) and M00505540 (GTIN: 00191506049171). The specific reason for the corrective action was not detailed in the notification, but users should follow the manufacturer's instructions. Affected devices should be identified, quarantined, and handled per Boston Scientific's guidance.
Tags: medical_device, fsca, switzerland, suture_tightener, boston_scientific, recall
Swissmedic FSCA for Boston Scientific Suture Cinch–Long (Model M00505550)
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for the Boston Scientific Suture Cinch–Long, a single-use suture/ligature tightener, model M00505550 (GTIN: 00191506049188). The reason for the corrective action is not specified in this notification. Healthcare facilities using this device should follow the manufacturer’s instructions, which may include quarantine and return of affected units.
Tags: field_safety_corrective_action, swissmedic, surgical_device, boston_scientific
Swissmedic FSCA for Maquet Critical Care Flow-i and Flow-e Anesthesia Workstations
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for Maquet Critical Care AB's Flow-i C20, C30, C40, Flow-c, and Flow-e general-purpose anesthesia workstations. The notice identifies affected model numbers and article codes, including various Flow-i configurations. Users should consult the manufacturer's correction instructions and implement the recommended actions to maintain device safety and performance.
Tags: swissmedic, fsca, anesthesia_workstation, maquet_critical_care
FSCA: Fritz Stephan GmbH Eve Neo Ventilators, Models 107061420 & 107061401
2026-07-14 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Fritz Stephan GmbH's Eve Neo adult and paediatric/neonatal pulmonary ventilators, affecting models 107061420 and 107061401. The specific reason for the corrective action was not detailed in the public notice, but it involves a safety-related issue. Affected users should immediately consult the manufacturer's instructions provided through the FSCA and implement any required corrective measures to ensure safe device operation.
Tags: swissmedic, fsca, ventilator, field_safety_corrective_action, fritz_stephan, eve_neo
Safety Alert: Oxylog 600 Ventilators from Fritz Stephan GmbH (Models 107161400, 107161401)
2026-07-14 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action (FSCA) for Oxylog 600 adult and paediatric/neonatal pulmonary ventilators manufactured by Fritz Stephan GmbH. The action affects models 107161400 and 107161401. The specific reason was not detailed in this alert, but users should follow the manufacturer's safety notice and implement any required corrective measures immediately.
Tags: fsca, ventilator, safety_alert, swissmedic, recall
Eve In - Fritz Stephan GmbH
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Adult and paediatric/neonatal pulmonary ventilators. Reason: . Model: 107061410, 107061411; .
BLEPHADEMODEX Sterile Skin-Cleaning Wipe: Swissmedic FSCA by Laboratoires Théa
2026-07-10 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for BLEPHADEMODEX, a sterile skin-cleaning wipe manufactured by Laboratoires Théa. The reason for the corrective action has not been specified in the notice. Affected model and lot numbers are not detailed; however, users should immediately quarantine the product and follow the manufacturer's instructions for return or disposal. This action underscores the importance of sterility assurance in medical devices.
Tags: fsca, swissmedic, sterile_wipe, medical_device, recall, laboratoires_thea, blephademodex
Swissmedic FSCA: Getinge Disinfection AB Warming Cabinets Model 363 – General-Purpose Drying Cabinet
2026-07-09 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Getinge Disinfection AB's general-purpose drying cabinet, marketed as warming cabinets, model 363. The specific reason for the corrective action is not detailed in the notice, but the manufacturer is taking necessary measures to address a potential safety or performance issue. Affected users should follow the manufacturer's instructions provided through the FSCA and contact Getinge Disinfection AB for further guidance.
Tags: swissmedic, fsca, warming_cabinet
Swissmedic FSCA: Comecer IRIS Infusion Pump – Added German Language Version (Model 0246010026)
2026-07-08 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action for Comecer Netherlands B.V.'s IRIS infusion pump, model number 0246010026. The action was taken to provide a German language version of the device documentation, addressing the risk of use errors among German-speaking users. Affected units should be updated with the new German documents following the manufacturer's instructions.
Tags: swissmedic, fsca, infusion_pump, comecer, german_language, product_correction
Swissmedic Issues FSCA for Philips Allura Stationary Angiographic X-Ray Systems
2026-07-08 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for Philips Allura stationary angiographic X-ray systems manufactured by Philips Medical Systems Nederland B.V. The affected models are 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058. Although the specific reason for the corrective action was not detailed in the notice, users are required to contact Philips immediately for instructions to ensure safe operation.
Tags: swissmedic, fsca, philips_allura, angiographic_x_ray, medical_device_recall
Swissmedic FSCA: BAL Flush Syringe SS, 10 ml by Jiaxing Tianhe Pharmaceutical
2026-07-07 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the BAL Flush Syringe SS, 10 ml (model BAL 464013) manufactured by Jiaxing Tianhe Pharmaceutical Co., Ltd. The specific reason for the corrective action has not been disclosed, but it concerns the pre-filled syringes. Healthcare facilities should identify affected products, quarantine them, and follow the manufacturer's instructions for return or disposal.
Tags: swissmedic, fsca, medical_device, prefilled_syringe, recall
Swissmedic FSCA: Boston Scientific Rapid Refill Continuous Injection System Cholangiography Tubing Set
2026-07-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Boston Scientific Rapid Refill Continuous Injection System, specifically the Cholangiography tubing set (GTIN 08714729285151, UPN M00566001). The reason for the corrective action is detailed in the manufacturer's notification. Healthcare facilities should identify affected devices, quarantine them, and follow Boston Scientific’s instructions to mitigate any safety risks.
Tags: swissmedic, fsca, boston_scientific, cholangiography_tubing, medical_device, safety_corrective_action, switzerland
Swissmedic FSCA: Automated Impella Controller by Abiomed – Models 0042-0040, 0042-0010, 0042-0000 and variants
2026-07-06 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a field safety corrective action (FSCA) for the Automated Impella Controller (AIC) manufactured by Abiomed Inc. The affected devices are intracardiac circulatory assist axial-pump catheter control units with model numbers 0042-0040, 0042-0010, 0042-0000, and their EU/UK variants. While the specific reason is not detailed in the notice, users should consult the manufacturer’s instructions for the required corrective actions to ensure patient safety.
Tags: swissmedic, fsca, impella, heart_pump, abiomed, safety_alert, cardiac_assist
FSCA: B. Braun Infusomat Space P Single-Channel Infusion Pump (Model 8713070)
2026-07-02 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the B. Braun Melsungen AG Infusomat Space P bedside infusion pump, model 8713070. The reason for the corrective action is not detailed in the brief notice, but it signals a potential safety issue requiring user attention. Healthcare facilities using this device should immediately consult the full FSCA on the Swissmedic portal and follow the manufacturer's recommended actions to mitigate any risk.
Tags: swissmedic, fsca, infusion_pump, safety, b_braun, field_safety_corrective_action
Swissmedic FSCA: Olympus Single Use Distal Cover (MAJ-2315) Patient Protection Cap
2026-07-01 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Olympus Single Use Distal Cover, a single-use endoscope patient protection cap. The affected model is MAJ-2315 and lot N6192000. While the specific reason for the corrective action was not detailed in the notification, users should immediately identify and quarantine affected products and follow Olympus' instructions to mitigate potential risks.
Tags: swissmedic, fsca, olympus, distal_cover
Swissmedic FSCA for SY-LAB IceCube Linear Rate Medical Freezers
2026-07-01 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for SY-LAB IceCube medical freezers with linear rate control, affecting models 11XS MED, 14S MED, 14M MED, 17M MED, 17L MED and their non-MED variants. The specific safety reason was not published in the initial notice. Users in laboratories and healthcare settings should immediately review the full FSCA on the Swissmedic portal and follow the manufacturer's corrective measures.
Tags: swissmedic, fsca, medical_freezer, laboratory_equipment, safety_correction
FSCA for Medline MEDSTOP Stopcock: New Language Added to Labeling
2026-06-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a field safety corrective action for the MEDSTOP stopcock manufactured by Medline Industries LP. The corrective action involves adding a new language to the device labeling to meet regulatory requirements. Affected models are identified by their Field Safety Notice (FSN). Distributors and healthcare facilities should ensure the updated labeling is used.
Tags: stopcock, labeling_update, field_safety_corrective_action, medline, swissmedic
FARADRIVE Steerable Sheath: Swissmedic FSCA for Added Language to Labeling
2026-06-16 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for Boston Scientific's FARADRIVE Steerable Sheath, a single-use vascular guide-catheter. The reason is the addition of a new language to the product labeling, categorized as a correction. Affected models are referenced in the FSN; users should update and follow the revised instructions for use.
Tags: swissmedic, fsca, labeling_update, steerable_sheath, boston_scientific
Swissmedic FSCA: Armstrong Medical PEP Therapy APL Valve – Language Addition to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic Field Safety Corrective Action (FSCA) concerns the APL Valve used in Positive Expiratory Pressure (PEP) Therapy Devices from Armstrong Medical Limited. The reason for the correction is the addition of a new language to the device labeling, likely to meet local regulatory language requirements. Affected models are listed in the Field Safety Notice (FSN). No direct patient safety issue is involved; users should follow the updated labeling instructions.
Tags: swissmedic, fsca, medical_device, labeling_update, pep_therapy, armstrong_medical, apl_valve
Swissmedic FSCA: Armstrong Medical Adult Coaxial Breathing Systems APL Valve - Added Language to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic FSCA addresses Armstrong Medical Limited's Adult Coaxial Breathing Systems, specifically the APL valve. The corrective action adds a new language to the device labeling or instructions for use, ensuring compliance with Swiss official language requirements. Affected models are detailed in the related Field Safety Notice (FSN). Users should verify they have the updated labeling and follow the manufacturer's instructions.
Tags: swissmedic, fsca, breathing_system, armstrong_medical, labeling_update, apl_valve, language
Swissmedic FSCA: Armstrong Medical Resuscitation Sets (Mapleson Systems) – APL Valve Labeling Language Update
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action addresses Armstrong Medical Limited's Resuscitation Sets (Mapleson Systems) where the APL valve labeling required a new language addition. Affected models are listed in the Field Safety Notice (FSN). Users are advised to consult the FSN and ensure the updated labeling is integrated into the instructions for use. This is a documentation correction, not a safety defect.
Tags: swissmedic, fsca, labeling_correction, resuscitation_set, armstrong_medical
Swissmedic FSCA: Paediatric Ayres T‑Piece Systems – APL Valve Label Updated with New Language
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Armstrong Medical Limited's Paediatric Ayres T‑Piece Systems (Resuscitation Set) affecting the APL Valve. The corrective action involves adding a new language to the device labelling to ensure proper use. Affected models are detailed in the Field Safety Notice (FSN); users should review the updated instructions and share the notice with relevant personnel.
Tags: swissmedic, fsca, medical_device, labeling_correction, pediatric_resuscitation, apl_valve
Swissmedic Expands °M Warmer FSCA: 7 More Lots Affected for MEQU A/S Blood/Fluid Warmer
2026-05-11 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has updated the Field Safety Corrective Action (FSCA) for MEQU A/S's °M Warmer, a conduction blood/fluid warmer, expanding the affected scope to include 7 additional lots. The correction applies to models MWS201 (Box of 5) and MWS201W (Single in Silver Pouch). Users should identify impacted devices and follow the manufacturer's instructions provided in the original FSCA notice.
Tags: swissmedic, fsca, blood_fluid_warmer, mequ, lot_expansion
Swissmedic FSCA: Staar Surgical AG IOD Software – New Information for Ophthalmology Instruments
2026-04-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for IOD Software, a software accessory manufactured by Staar Surgical AG used with various ophthalmology instruments. The corrective action stems from new information about the software, though affected model or lot details are not specified. Users of the impacted software should follow recommended actions such as applying updates or contacting the manufacturer to maintain safe and effective operation.
Tags: swissmedic, fsca, ophthalmology, software
FSCA Update for Maquet Cardiohelp II Base Unit (Model 701077135) – Change in Corrective Actions
2026-04-29 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for Maquet Cardiopulmonary GmbH's Cardiohelp II Base Unit, a roller-type cardiopulmonary bypass system. This notice concerns a change in the corrective actions previously communicated for model 701077135. Affected users should review the updated instructions from the manufacturer and implement the revised measures to maintain device safety.
Tags: fsca, cardiopulmonary_bypass_system, corrective_action_update, swissmedic
Updated Safety Measures for ELEC plus Ceramic Ball Head Hip Component – ARTIQO GmbH
2026-04-27 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the ELEC plus Keramik-Kugelkopf (ceramic ball head), a femoral component of hip joint prostheses manufactured by ARTIQO GmbH. The FSCA communicates updated measures; specific affected models are listed in the manufacturer's Field Safety Notice. Healthcare facilities should immediately review the revised notice and implement the recommended actions to ensure patient safety.
Tags: hip_prosthesis, ceramic_ball_head, field_safety_corrective_action, swissmedic, medical_device_recall, arthroplasty
Swissmedic FSCA: Sphere-9 Catheter – Updated Field Safety Notice (Medtronic/BIOTRONIK)
2026-03-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Sphere-9 Catheter (Model AFR-00001), manufactured by Medtronic, Inc. and BIOTRONIK SE & Co. KG. The reason is a new version of the Field Safety Notice (FSN) for this cardiac tissue ablation device. Affected users should review the updated FSN and implement any revised instructions.
Tags: fsca, cardiac_ablation_catheter, field_safety_notice
Swissmedic FSCA: Vue PACS Additional Software Versions Affected
2026-03-11 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has updated a field safety corrective action for Philips Medical Systems Nederland B.V. Vue PACS radiological software (model 1017979). The update includes additional software versions now affected by the issue. Users should review the manufacturer's notice and apply any required software updates or mitigations.
Tags: fsca, swissmedic, vue_pacs, philips, radiology_software, product_correction
Follow-up Field Safety Notice for ORBIS Medication 3.x by DH Healthcare GmbH
2026-01-23 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a follow-up Field Safety Corrective Action (FSCA) for ORBIS Medication 3.x, a medical device software from DH Healthcare GmbH. This notice provides additional information supplementing previously issued Field Safety Notices (FSNs). Affected model numbers are not specified in the notice. Users should review the updated safety information and follow the manufacturer’s recommendations.
Tags: swissmedic, fsca, field_safety_notice, follow_up, medical_device_software, dh_healthcare, orbis_medication
Zimmer Tourniquet Systems: Field Safety Corrective Action for Serial Number Update (Models 60500010100, 60320010100)
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Zimmer Surgical, Inc. has issued a Field Safety Corrective Action (FSCA) for the Zimmer Tourniquet Systems concerning models 60500010100 and 60320010100. The reason is to update serial numbers, which may involve correcting records or labeling to maintain traceability. Affected users should follow the manufacturer’s instructions to verify and update the serial numbers as required.
Tags: swissmedic, fsca, tourniquet_system, serial_number_update, zimmer_surgical
Zimmer Tourniquet Systems Serial Number Update – Swissmedic FSCA
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a Field Safety Corrective Action for Zimmer Surgical's pneumatic tourniquet systems (models 60500010100, 60320010100). The corrective action is to update serial numbers, likely due to labeling or documentation discrepancies. Affected users should follow manufacturer instructions to verify and update the serial numbers; no product recall or return is required.
Tags: swissmedic, fsca, zimmer_surgical, tourniquet_system, serial_number_update
Philips Azurion System FSCA: Additional Language Versions of Field Safety Notice V2
2025-12-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for Philips Medical Systems Nederland B.V. concerning stationary angiographic X-ray systems Azurion (models 722229–722236). The action is a product correction where Philips added new language versions for the existing Field Safety Notice (FSN V2) to improve distribution. No defect or safety risk is involved; affected users should note the updated notice availability.
Tags: fsca, philips, angiographic_system, field_safety_notice, swissmedic
Medin-NC3 Neonatal CPAP Unit: New Blower and Software Update Available – Swissmedic FSCA
2025-08-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action for the Medin-NC3 neonatal CPAP unit (model 3000) from medin Medical Innovations GmbH. The manufacturer is making a new blower and a software update available to improve device performance or safety. Users should contact the manufacturer to schedule the correction.
Tags: swissmedic_fsca, neonatal_cpap, product_correction