Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BK Medical ApS, FMI 87010, Ultrasound system type 2300

   BK Medical, een bedrijf van GE HealthCare, is zich bewust geworden van een probleem met de Dual Live Compare-functie op het ...

   Waarschuwing | 04-01-2024

2. B.Braun Melsungen AG, Introducer Needle

   Tijdens activiteiten voor postmarkttoezicht en onze interne kwaliteitscontroles hebben we vastgesteld dat bij de vermelde ...

   Waarschuwing | 03-01-2024

3. Medex, FSCA 23024, Secufill

   Some particulates have the potential to detach from the device and, in rare circumstances, might enter the fluid path and be ...

   Waarschuwing | 20-12-2023

4. 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

5. Philips Medical Systems Nederland BV, 2023-IGT-BST-024, Philips Azurion 7 M20 FlexArm system with Maquet M

   If, during a procedure, the detector is positioned at a distance of approximately four (4) cm from the patient, the connection ...

   Waarschuwing | 15-12-2023

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

   Philips has identified a potential issue which can cause the system to continuously restart (restart loop). This is likely to ...

   Waarschuwing | 15-12-2023

7. Philips Medical Systems Nederland B.V., 2023-PD-CTAMI-010, Spectral CT 7500

   Philips has identified multiple software issues affecting Spectral CT 7500 systems. The detailed descriptions of these issues are ...

   Waarschuwing | 14-12-2023

8. Siemens Healthcare GmbH, AX060/23/S (FSCA), AX061/23/S (FSN), ARTIS icono ceiling

   When the ARTIS icono ceiling system was switched off for a longer time (e.g. overnight) and switched on, this collision sensor is ...

   Waarschuwing | 01-12-2023

9. Philips Medical Systems Nederland B.V., 2023-PD-CTAMI-015, Brilliance CT Big Bore; Philips CT Big Bore

   Na het uitvoeren van een niet-gecentreerde reconstructie en het verzenden van de beeldgegevens naar andere TPS-werkstations ...

   Waarschuwing | 01-12-2023

10. Shimadzu Corporation, FMRBR-23H025, FDR Visionary Suite

    The CEILING TUBE SUPPORT for the above device consists of an X-ray Tube Support Pull-up Section and an X-ray Tube Support Section ...

    Waarschuwing | 28-11-2023