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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

538 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Datascope Corp. Getinge, FSN-2249723-03/01/2021-001-C, Cardiosave Intra-Aortic Balloon Pumps

    Datascope/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue ...

    Waarschuwing | 31-03-2021

  2. Philips Medical Systems, FSN-FSCA 86100229A-IR, Philips HeartStart FR2+/FRx/HS1 (Onsite)/HS1 (Home) AED

    URGENT Veiligheidsbericht HeartStart HS1 Home, HS1 Onsite, FRx en FR2/FR2+. Apparaten zijn mogelijk weggelaten uit eerdere ...

    Waarschuwing | 04-03-2021

  3. Physio-Control, Inc., FSN-RA2021-2600240, LIFEPAK® CR2 DEFIBRILLATOR

    Stryker is conducting a voluntary action to notify customers with certain LIFEPAK CR2 devices manufactured with lids identified ...

    Waarschuwing | 17-02-2021

  4. Maquet Cardiopulmonary GmbH, FSN-FSCA-2021-01-11, Customized Tubing Sets

    Maquet Cardiopulmonary GmbH became aware of a missing cable tie in the cardioplegia (Plegiox) line to secure the connection ...

    Waarschuwing | 21-01-2021

  5. Spacelabs FSCA Sentinel 9 - Model 98200 & 98201 Bad Upgrade

    During upgrade from Sentinel V9 or below to any later version, incorrect comments may be added to existing reports stored in the ...

    Waarschuwing | 15-12-2020

  6. Medtronic Inc., FSN-FA925 Phase II, Cobalt XT DR/VR MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Crome VR/DR MRI SureScan

    Medtronic’s internal processes identified ten (10) devices underwent a specific manufacturing sequence that may have introduced a ...

    Waarschuwing | 27-11-2020

  7. Maquet FSCA-2020-08-14 - Heater-Cooler Unit HCU 40

    Maquet Cardiopulmonary GmbH has received isolated complaints in relation to heat damage of the cable insulation at the crimp ...

    Waarschuwing | 02-10-2020

  8. Datascope Corporation, FSN-2248146-05/29/2020-001-R, Datascope Intra-Aortic Ballon Catheters (IABs)

    Datascope/Getinge is initiating a voluntary Recall-Removal involving certain Intra-Aortic Balloon Catheters (IABs) that may not ...

    Waarschuwing | 06-08-2020

  9. Maquet FSCA-2020-08-06 - Heater-Cooler Unit HCU 40

    Maquet Cardiopulmonary GmbH has received complaints in relation to leaking vacuum valves of the HCU 40.

    Waarschuwing | 06-08-2020

  10. Philips FSCA 86100212A - HeartStart MRx Defibrillator_Monitor

    Philips identified that the HeartStart MRx Monitor/Defibrillator Therapy Selector Switch may fail, resulting in abnormal device ...

    Waarschuwing | 09-07-2020

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