Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Intersurgical Ltd, FSN-414091, Superset Fixed Elbow Catheter Mount 22F-22M/15F

   We have received reports of the patient elbow disconnecting from the Superset tube in a number of products.

   Waarschuwing | 13-06-2023

2. Atrium Medical Corporation, 3011175548-08.18.2023-001-C, Atrium Ocean Water Seal Chest Drains

   The Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution ...

   Waarschuwing | 03-10-2023

3. Intersurgical Ltd CAPA 226766 - Nebulizing system delivery set.Anaesthesia breathing circuit.Ventilator breathing circuit.Catheter mount.Anaesthesia face mask

   We have received complaints about cracked ports in the swivel elbow where the flip cap is inserted, and these cracks leak if they ...

   Waarschuwing | 15-07-2019

4. Teleflex Medical EIF-000506 - Arrow 3-Lumen Central Venous Catheters (CVC) Set

   Arrow International LLC, een dochteronderneming van Teleflex, start een vrijwillige corrigerende veiligheidsmaatregel (‘Field ...

   Waarschuwing | 24-05-2022

5. Medtronic, Inc., FSN-FA952, Strata II, Delta and Flow Control Valve

   Het doel van deze brief is u te informeren over een mogelijke variatie in zichtbaarheid van radiopaque markeringen tijdens ...

   Waarschuwing | 15-01-2021

6. Inpeco SA, FSCA - AP2 - 202303 - 03, Aptio Automation

   The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

   Waarschuwing | 14-03-2023

7. Inpeco SA, FSCA - ACP - 202303 - 02, Accelerator a3600

   The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

   Waarschuwing | 14-03-2023

8. Inpeco SA, FSCA - FLX - 202303 - 01, FlexLab

   The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

   Waarschuwing | 14-03-2023

9. Datex-Ohmeda Inc, FSN-FMI 32076, Giraffe Omnibed/Giraffe Incubator

   GE Healthcare has become aware that certain Giraffe Incubators and Giraffe OmniBeds manufactured before 2012 can deliver a ...

   Waarschuwing | 18-05-2020

10. Inpeco S.A. FSCA - AP2 - 202003 - 03 Aptio Automation

    The Centrifuge Module tube loading algorithm included in the firmware versions mentioned above is not in compliance with the ...

    Waarschuwing | 23-03-2020