Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BIOTRONIK, 200000470, Dynetic-35

   During an in-house inspection, Biotronik discovered that a few sterilization pouches of the Passeo-35 Xeo and Dynetic-35 were ...

   Waarschuwing | 03-12-2021

2. Cardiac Pacemaker Inc, FSN-92289212-92705305-FA, Pacemakers from the INGENIO™ EL family and the ACCOLADE™ family

   Urgente veiligheidskennisgevingen: INGENIO™ productfamilie DR EL Pacemakers en CRT-P’s (92705305-FA) en Door waterstof ...

   Waarschuwing | 03-06-2021

3. Medtronic FA944 - HeartWare™ Ventricular Assist Device (HVAD™) System - update May 2021

   In augustus 2018 heeft Medtronic deze veiligheidskennisgeving voor het eerst aan een aantal gebruikers gestuurd, samen met ...

   Waarschuwing | 01-05-2021

4. 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

5. Maquet_Getinge FSCA-2020-12-07 - Pediatric Venous Hardshell Cardiotomy Reservoir

   During verification testing of Pediatric VKMOs and VHKs a potential impairment of the sterile packaging barrier system was ...

   Waarschuwing | 16-12-2020

6. 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

7. 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

8. Cardiac Pacemaker Inc, FSN-92628736-FA, EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD

   Urgente veiligheidskennisgeving inzake EMBLEM™ subcutane implanteerbare cardioverter defibrillatoren (S-ICD's) (Modellen A209 en ...

   Waarschuwing | 03-12-2020

9. 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

10. 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