Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Philips Goldway Shenzhen Industrial Inc., Philips HeartStart Intrepid Monitor.Defibrillator

   Er zijn directe en verborgen storingen waargenomen waarbij op het apparaat de melding "Equipment Disabled: System Failure" ...

   Waarschuwing | 02-08-2023

2. Equimedical BV, 2-2023, Equitamp and Equicel and equispon

   In March 2023 the Health and Youth Care Inspectorate (NL) received a compliance and enforcement request (CEF) fom Agentia ...

   Waarschuwing | 31-07-2023

3. Kimetec GmbH, FSCA-2023-001, CBC NUCOS

   Due to sharp-edged structures inside the vein tourniquet buckle of the affected production batches, friction can cause damage to ...

   Waarschuwing | 31-07-2023

4. Medtronic, FA1326, Cobalt XT.Cobalt.Crome ICDs and CRT-Ds

   Zeldzame mogelijkheid van verminderde of geen energie-output tijdens hogespanningstherapie in implanteerbare ...

   Waarschuwing | 19-07-2023

5. Maquet Cardiopulmonary GmbH, 812435, Rotaflow II drive flex.compact

   In October 2022 Maquet Cardiopulmonary received a complaint on issues connected to the yellow locking mechanism unlocking on ...

   Waarschuwing | 11-07-2023

6. NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve

   NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf not identified prior to ...

   Waarschuwing | 11-07-2023

7. Covidien IIc, MAHURKAR Triple Lumen Catheter and MAHURKAR High Pressure Triple Lumen Catheter

   Tijdens tests in verband met de fabricage werd vastgesteld dat het lumen in het midden van de katheter een occlusie had in de tip ...

   Waarschuwing | 06-07-2023

8. Datascope Corp., 2248146-06.12.2023-001-R, Datascope Intra-Aortic Balloon Catheter IABs

   There have been Customer reports of the introducer dilator included within Datascope/Getinge IAB insertion kits fracturing at the ...

   Waarschuwing | 29-06-2023

9. GE Vingmed Ultrasound AS, FMI 76195, Vivid S60 N Vivid S70 N

   GE HealthCare is zich ervan bewust geworden dat bepaalde Vivid-echografiesystemen niet tijdig kunnen opstarten. Als dit gebeurt, ...

   Waarschuwing | 28-06-2023

10. SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®

    Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of ...

    Waarschuwing | 27-06-2023