Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Philips Medical Systems Nederland BV, 2023-IGT-BST-012, Philips Azurion

   Het Philips Azurion-systeem bevat een Certeray-generator die een storing kan ondervinden als gevolg van een mogelijke ...

   Waarschuwing | 22-02-2024

2. Siemens Healthcare GmbH, AX044/22/S (FSCA), AX045/22/S (FSN), ARTIS pheno / icono

   During transversal table movement, it could happen that the rolling bearing may get dislocated; it is part of the linear guide ...

   Waarschuwing | 13-02-2024

3. HS Hospital Service, REC 23-246.8, AMICA GEN

   The user reported that, during a radiofrequency ablation of a thyroid nodule, the generator displayed an impedance higher  than ...

   Waarschuwing | 29-01-2024

4. Update - Philips Medical Systems Nederland BV, 2023-IGT-BST-005, Philips Azurion

   Philips heeft een mogelijk probleem vastgesteld waardoor het systeem continu opnieuw wordt opgestart (herstart-loop). Dit gebeurt ...

   Waarschuwing | 25-01-2024

5. Philips Medical Systems Nederland B.V., 2023-PD-CTAMI-019, Philips BrightView, X, XCT

   Philips is op de hoogte gebracht van een mogelijk veiligheidsprobleem dat van invloed is op BrightViewsystemen, waarbij de ...

   Waarschuwing | 16-01-2024

6. Siemens Shanghai Medical Equipment Ltd., XP044/23/S, LUMINOS Impulse; Luminos RF Classic; Luminos Select; AXIOM Iconos MD; AXIOM Iconos R100

   This letter is to inform you about a prev entive measure to exclude any potential risk of patient injury caused by t he footrest ...

   Waarschuwing | 19-12-2023

7. Siemens Healthcare GmbH, XP056/23/S, XP047/23/S, Luminos dRF/Max;Agile Max;Ysio/Max/X.pree

   Following a complaint, it was identified that during system installation the mounting of the BABIX holder was possibly performed ...

   Waarschuwing | 31-10-2023

8. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, FMI 78099, Venue Go

   GE HealthCare has become aware that some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt ...

   Waarschuwing | 17-10-2023

9. 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

10. Siemens Healthcare, UI XP051/22/S, AXIOM Iconos R100; R200 C20+C90; AXIOM Luminos TF

    Potential risk of foot rest detaching from the patient table  

    Waarschuwing | 15-12-2022