Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Teleflex EIF-000419 - RUSCH® GREENLITE™ Mac-laryngoscopen

   Teleflex roept vrijwillig de bovenstaande producten terug omdat klanten hebben gemeld dat de lichtgeleider van de Rüsch® ...

   Waarschuwing | 08-07-2020

2. Maquet Critical Care AB, MCC.23.003.IU, Servo-n

   Getinge received one complaint that HFOV was not performing as expected for patients with certain body weights, with regard to ...

   Wob-verzoek | 02-02-2024

3. Respironics, Inc., 2023-CC-SRC-039, BiPAP A30 Ventilator (Respironics, Inc.)

   Alle BiPAP A30-, BiPAP A30 EFL-, BiPAP A30 Hybrid-, BiPAP A40-, BiPAP A40 EFL-, BiPAP A40 Pro-apparaten Onderbrekingen en/of ...

   Waarschuwing | 15-04-2024

4. Field Safety Notice: ResMed, Astral 100, Astral 100SC en Astral 150 ventilatoren

   ResMed heeft een klein aantal meldingen ontvangen over de werking van de interne accu, waarbij de onterechte activering van een ...

   Waarschuwing | 27-07-2017

5. Intersurgical Ltd, 446776, Various Mapleson F Anaesthetic Breathing Systems

   Some devices contain a reservoir bag with a closed tail, when they should have a reservoir bag with open tail.    

   Waarschuwing | 06-05-2024

6. GE Healthcare Finland Oy, FSN-FMI 39004, TruSignal® SpO2 Sensors

   Issue 1: Affected TruSignal SpO2 Sensors (see Table 1 below) can potentially reduce the amount of electrical energy reaching the ...

   Waarschuwing | 06-07-2023

7. GCE, s.r.o., sukls 264995/2021, COMBILITE SERIES

   Bij gebruik van de pure zuurstof met COMBILITE® SERIES drukreduceerventielen in combinatie met drukcilinder - is een zeer beperkt ...

   Waarschuwing | 29-10-2021

8. Full Vision Inc, FSCA 20230519, Trackmaster Treadmills

   When given a start command from the integrated controller or attached stress system, the Drive and Motor is intended ...

   Waarschuwing | 10-11-2023

9. NOxBOX Ltd, VIG-23-03, NOxBOXi

   NBL has worked with the third-party supplier of the manifold to investigate this issue and has determined that the malfunction is ...

   Waarschuwing | 31-05-2023

10. Philips Respironics, 2023-CC-SRC-003, Trilogy

    Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate ...

    Waarschuwing | 14-04-2023