Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Airel, 24_FSN_001, UNIT K2

   However, during assembly, a case of a screw breaking (see image below) was observed. Analysis and investigations have shown that ...

   Waarschuwing | 08-04-2024

2. United Care Products B.V., 2024-01-2717-73, Sherpa 2 Compact Spreader Bar

   Volgens de waarschuwing in de gebruiksaanwijzing kan het gebruik van dit hulpmiddel in een vochtige omgeving of in een omgeving ...

   Waarschuwing | 04-04-2024

3. Perouse Medical,CAPA24.010,Guidewire Introducer.Octoflux and Algaflex

   PEROUSE MEDICAL became aware of a problem related to the blister packs of some of its products. There could be a rupture of the ...

   Waarschuwing | 03-04-2024

4. Fritz Stephan GmbH, QS.19-14434, EVE IN; EVE TR; EVE NEO

   Fritz Stephan GmbH was informed about a case in which toggling of the measured value display resulted in ventilator failure.  

   Waarschuwing | 28-03-2024

5. Sleepnet Corporation, 2024-FSN-1, Mojo + Mojo2+iQ 2+Phantom 2

   Maskers met magneten van Sleepnet Corporation – Potentiële magnetische interferentie met bepaalde medische producten. In dit ...

   Waarschuwing | 14-03-2024

6. GeneProof a.s., FSCA 00623(b), GeneProof Enterovirus PCR Kit

   Op basis van feedback van klanten hebben we de potentiële aspecificiteiten van de GeneProof Enterovirus PCR Kit onderzocht met ...

   Waarschuwing | 12-12-2023

7. Drägerwerk AG & Co. KGaA, PR136065, Atlan Family

   Within our market surveillance activities regarding our anesthesia workstation Atlan we be­ came aware of a few cases in which ...

   Waarschuwing | 05-12-2023

8. Mölnlycke Health Care AB, 2023-09(04), ® Trays with S.R.R Component Affected Products numbers globally

   De hendel (handgreep) die tijdens de ingreep wordt gebruikt om de bladen van elkaar te scheiden, was aan de verkeerde kant van ...

   Waarschuwing | 27-11-2023

9. Siemens Healthcare GmbH, MR072/23/S, Over-ear headphones

   In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or ...

   Waarschuwing | 10-11-2023

10. CareDx Pty Ltd, NCR-2023-039, AlloSeq Assign

    The Ctrl+G shortcut and the P only or G only selections in the Report Display Options are removing the expression variant ...

    Waarschuwing | 19-10-2023