Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Teleflex Malaysia Sdn Bdh Malaysia, EIF-000527, Rüsch EndoGuide T

   This voluntary FSCA for the above-listed products has been initiated due to a potential for the plug to detach from the tip of ...

   Waarschuwing | 26-01-2023

2. Acutronic Medical Systems AG, FSN-FSCA-21-004, fabian HFOi

   Bias Flow selection buttons unavailable in the User Interface following incorrect selection of device configuration during a ...

   Waarschuwing | 08-04-2022

3. Medtronic Xomed, Inc., FSN-FA1218, NIM Trivantage™ EMG Endotracheal tube

   Medtronic is voluntarily recalling specific production lots of EMG Tube NIM Trivantage. Medtronic has received complaint reports ...

   Waarschuwing | 18-01-2022

4. Maquet Critical Care AB, MCC-21-005-IU, Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e

   Maquet Critical Care has received eight complaints describing the presence of a yellow substance in the vaporizer.

   Waarschuwing | 07-01-2022

5. Löwenstein Medical Innovation GmbH & Co. KG, FSN-FSCA 2021_001, elisa 300, elisa 500, elisa 600, elisa 800 (VIT)

   Löwenstein Medical Innovation GmbH & Co. KG has announced new software  versions, 2.09.4 and 2.04.4, for the elisa devices.

   Waarschuwing | 04-05-2021

6. Acutronic Medical Systems AG, FSN-FSCA-21-001, fabian HFO, +nCPAP evolution and Therapy evolution

   The purpose of this communication is to inform you of a product Field Safety Corrective Action involving the fabian Therapy ...

   Waarschuwing | 27-04-2021

7. B. Braun Medical B.V. FSCA-2019-07-02 SK/AS - Anaesthesia conduction filter

   During the production it was identified that the membrane in the Perifix filter may not fulfil the specified requirements. The ...

   Waarschuwing | 02-07-2019

8. Teleflex Medical EIF-000427 - Lasertube (Rubber) Laser resistant tracheal tube; Endotracheal tube for laser surgery

   Teleflex Medical is een corrigerende veldveiligheidsactie gestart voor de bovengenoemde producten naar aanleiding van rapporten ...

   Waarschuwing | 18-06-2020

9. Uptake Medical Technology 12July2019 - InterVapor System

   Patiënten met bloedingsstoornissen, patiënten die antistollingstherapie ondergaan en patiënten met instabiele cardiovasculaire ...

   Waarschuwing | 12-07-2019

10. GE Healthcare FMI 34126 - Carescape R860, Engström Carestation, Engström Pro Ventilators

    Reservebatterijen in CARESCAPE R860-beademingsapparaten die op of na 1 april 2019 zijn geproduceerd en door GE Healthcare ...

    Waarschuwing | 31-05-2022