Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. Maquet Cardiopulmonary GmbH, FSN-FSCA-2020-07-31, Heater Unit HU 35, ROTAFLOW System and ROTAFLOW System with ROTAFLOW ICU Console

   Due to the update of the IEC Standard 60601-1-2 for Electromagnetic compatibility (EMC) to its 4th edition, the medical devices ...

   Waarschuwing | 05-08-2020

4. Siemens AX044_20_S - Sensis Vibe Hemo systems with MicroPod™ EtC02

   We already informed you by our notification AX048/20/S about the MicroPod EtCO2 issue. Following this information, we inform you ...

   Waarschuwing | 31-07-2020

5. LivaNova_Sorin HV-SAL-2020-001 - Dual Collapser

   De Dual Collapser is een onderdeel van de Perceval accessoire-kits voor éénmalig gebruik. De Dual Collapser wordt gebruikt om de ...

   Waarschuwing | 29-07-2020

6. Welch Allyn MOD1299 - Patient Cables or Lead Sets - update 27-7-2020

   Wanneer de kabels van de elektrocardiograaf op een patiënt blijven tijdens defibrillatie, kan de kabelset van de ...

   Waarschuwing | 27-07-2020

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. Maquet Critical Care AB, FSN-MCC 20 009 IU, Heart Lung Machine HL 40 occlusion clamp assembly

   This letter is to inform you that “hot swapping” the electro-mechanical venous occlusion clamp (EVOC) should be avoided while the ...

   Waarschuwing | 09-07-2020

9. GE Medical Systems Information Technologies Inc, FSN-FMI 36147, Carescape One

   CARESCAPE ONE biedt mogelijk geen visuele en auditieve alarmen voor ventriculaire fibrillatie (V Fib), als V Fib optreedt op het ...

   Waarschuwing | 08-07-2020

10. 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