Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Pulsion Medical Systems FA574697 - PiCCO Monitoring Kit + ProAQT Sensor

   We have identified that the listed products have been produced with packaging material that is suspected to have an uncoated ...

   Waarschuwing | 14-02-2022

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. CARDIONOVUM GmbH, FSN-FO-40 no.11/2019, LEGFLOW OTW/RX Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

   The purpose of this communication is now to draw your attention to updates that will be made to the IFUs for these devices ...

   Waarschuwing | 26-06-2020

9. Stryker Medical RA2020-2310673 - LIFEPAK® 500 AEDs

   Stryker has become aware that LIFEPAK 500 AEDs in high-use environments (Emergency Medical Services) may not detect a patient ...

   Waarschuwing | 16-06-2020

10. Philips Medical Systems FSCA 86100197A-IR Internal Sterilizable Defibrillator paddles

    Interne paddles kunnen na verloop van tijd slijten en zijn mogelijk niet veilig of gereed voor gebruik, tenzij de aanwijzingen in ...

    Waarschuwing | 24-04-2020