Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. GME German Medical Engineering GmbH, CAPA 20230928-5, FlexSys

   GME is currently preparing for certification within the new regulatory framework of the Medical Device Regulation (MOR). In case ...

   Waarschuwing | 15-12-2023

2. Ecolab Deutschland GmbH, ECL-FSCA-001, Incidin OxyWipe S; Incidin OxyFoam S

   Ecolab have retested the product’s efficacy of Incidin OxyWipe S and Incidin OxyFoam S against C. difficile according to the norm ...

   Waarschuwing | 15-12-2023

3. Mölnlycke Health Care AB, 2023-11(01), See attached Product Table

   Mölnlycke is onlangs op de hoogte gebracht van een actie die is geïnitieerd door Dispo Medical, de wettelijke fabrikant van het ...

   Waarschuwing | 14-12-2023

4. 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

5. DiaSys Deutschland Vertriebs-GmbH, NCR 24-12, GLDH FS DGKC

   Using the a.m. lots of GLDH FS DGKC cause falsely high results when measured in quality controls or patient samples

   Waarschuwing | 12-12-2023

6. Ameco Medical Industries, VIG-33-2023-FC03, AMECATH Short Term Haemodialysis Catheter

   Luxation of the catheter due to suture-wing detaching from catheter with lot number 21006

   Waarschuwing | 12-12-2023

7. Stihler Electronic GmbH, #2023-11 (FSN), #2024-01 (FSCA), ASTOPAD

   SOF and COV applied parts manufactured from May 2022 to October 2023 may potentially have internal (not visible from outside) ...

   Waarschuwing | 11-12-2023

8. ARDO medical AG, FSCA 2023-01, Master

   Some devices (Master) can overheat due to an incorrectly assembled circuit board and as a result therefore switches off. This ...

   Waarschuwing | 11-12-2023

9. Cardiac Pacemaker Inc, 92977025-FA, Model 3120 ZOOM PRM with Model 2892 Software

   Vanaf 10 januari 2024 geeft de klokparameter die wordt gebruikt door de softwaretoepassing van Model 2892 in de Model 3120 ...

   Waarschuwing | 11-12-2023

10. Olympus Medical Systems Corporation, QIL FY24-EMEA-29-FY24-EMEA-14-White Tape on Scope, Olympus Flexible Endoscopes

    Olympus recently received complaints indicating that the insertion tube of a repaired endoscope was wrapped with white tape. This ...

    Waarschuwing | 08-12-2023