Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Olympus Medical Systems Corporation, QIL FY24-EMEA-18-FY24-OMSC-24, Thunderbeat Type – S

   Olympus is taking this recall action after discovering that the Thunderbeat’s blue seal button may remain in the engaged ...

   Waarschuwing | 29-09-2023

2. Ace-medical Quality Management Dept., 202307-08-FSCA, AutoMer 2

   AutoMer 2 (A230214-E2MZ0000AT-1 was returned as a complaint device. Through the tests, Ace Medical found a problem with a ...

   Waarschuwing | 28-09-2023

3. Beaver Visitec International Inc, FA-23-002, Conventional Crescent Knife 2.5mm, 55 degrees

   BVI heeft feedback van een enkele klant ontvangen dat één partij van het artikelnummer 373807, conventioneel mes met gebogen ...

   Waarschuwing | 28-09-2023

4. Siemens Healthcare Diagnostics Inc., AIMC 23-08, Atellica IM Free Beta Human Chorionic Gonadotropin (FBHCG) ADVIA Centaur Free Beta Human Chorionic Gonadotropin (FBHCG)

   The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...

   Waarschuwing | 28-09-2023

5. IT2084135-Roche Diabetes Care GmbH-SB RDC 2023 04-Accu-Chek Solo system

   Informeren wij u vandaag ook over een potentieel risico dat de reservoirnaald gebogen kan worden of dat de pleister nat kan ...

   Waarschuwing | 27-09-2023

6. Roche Diabetes Care GmbH, SB RDC 2023 03, Accu-Chek Solo reservoir

   Informeren wij u vandaag over een potentieel risico dat de reservoirnaald gebogen kan worden of dat de pleister nat kan worden ...

   Waarschuwing | 27-09-2023

7. Philips Medical Systems Nederland BV, 2023-IGT-BST-004, Philips Allura Xper, Azurion and MultiDiagnost -El and MD Eleva systems

   The wired foot switch is used to control fluoroscopy, exposure, and other functions, such as single shot, light control, and ...

   Waarschuwing | 27-09-2023

8. Siemens Medical Solutions USA, Inc., MI10/23/S + MI11/23/S, Symbia Pro.specta

   This letter is to inform you of the possibility that during a whole-body planar scan with auto-contour, the short-linear drive ...

   Waarschuwing | 27-09-2023

9. Olympus Medical Systems Corporation, QIL FY24-EMEA-17-FY23-OMTA-43, Olympus Flexible Endoscopes with channels

   Olympus discovered that our channel air drying process was not validated, and that a small percentage of scopes returned to ...

   Waarschuwing | 25-09-2023

10. Siemens Medical Solutions USA, Inc., MI10/23/S + MI11/23/S

    This letter is to inform you of the possibility that during a whole-body planar scan with auto-contour, the short-linear drive ...

    Waarschuwing | 22-09-2023