Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Datascope Corp, 2249723-10/27/2021-003-C, Cardiosave Intra-Aortic Balloon Pumps

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

   Waarschuwing | 07-12-2021

2. Boston Scientific Corporation, FSN-92688876-FA, POLARSHEATH™ Steerable Sheath 12F (POLARSHEATH™)

   This Field Safety Notice provides important information regarding updates to the IFU for the POLARSHEATH™ Steerable Sheath 12F ...

   Waarschuwing | 22-04-2021

3. Mar-Med MM-FSA-01 - Uni-Cot, Tourni-Cot Universal

   In rare instances, the device may split into two pieces during removal leaving a portion of the device on the patient’s digit. If ...

   Waarschuwing | 04-12-2020

4. Schiller AG 1825884-FSCA - Tempus LS

   An inadvertent software error has been detected as part of intemal  production control activities for the Tempus LS. This issue ...

   Waarschuwing | 25-11-2020

5. Defibtech FA2020-01 - DDU-2000 Series Automated External Defibrillator (AED)

   This corrective action addresses a hardware issue with a particular electrical component used in the identified AEDs.  This ...

   Waarschuwing | 21-04-2020

6. Medtronic, Inc. FA908 HeartWare® Ventricular Assist System (HVAD)

   Van de bijna 22.000 HVAD-pompen die tot en met 5 maart 2020 zijn gedistribueerd, heeft Medtronic 92 klachten (0,42%) ontvangen ...

   Waarschuwing | 07-04-2020

7. Abbott Vascular 29 januari 2020 - NC Trek_Traveler RX Coronary Dilatation Catheter

   Abbott is gestart met een terugroeping van specifieke partijen van de NC Trek RX Coronaire dilatatiekatheter en NC Traveler RX ...

   Waarschuwing | 29-01-2020

8. GE Healthcare FMI 36142 - GE Central Stations en ApexPro Telemetrie-servers

   Er zijn kwetsbaarheden voor cyberaanslagen geïdentificeerd wanneer bepaalde versies van de CARESCAPE Telemetrie-server, Apex ...

   Waarschuwing | 27-01-2020

9. Stryker RA2020-2246951 - LIFEPAK® 15 Monitor/Defibrillator

   The company has become aware that certain LIFEPAK 15 Monitor/Defibrillators may not deliver a defibrillation shock when the ...

   Waarschuwing | 21-01-2020

10. SCHILLER AG 1816815-FSCA - Tempus LS

    SCHILLER AG received notice that under certain circumstances a defibrillation will not be possible. lt‘s possible that an ...

    Waarschuwing | 21-11-2019