Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Teleflex Medical EIF-000369 DispoGrip

   Teleflex Medical is issuing a Field Safety Advisory Notice for the product referenced above due to a labelling error on the outer ...

   Waarschuwing | 06-09-2019

2. Respironics California, LLC FSCA 86600042A-IR, FSCA 86600043A-IR, FSCA 86600044A-IR, FSCA 86600045A-IR V60 & V680 Ventilators

   The touchscreen must be used to change certain therapy settings. The touchscreens in affected units may become frozen and fail to ...

   Waarschuwing | 30-08-2019

3. Datex-Ohmeda, FMI 34101, Aespire 7100, Aestiva 7900/MRI/7100/100

   ICS advies - Beveiligingskwetsbaarheid van bepaalde GE-anesthesiesystemen als deze zijn aangesloten op een onvoldoende beveiligde ...

   Waarschuwing | 14-08-2019

4. Intersurgical, 238507, Economy Anaesthetic Face Mask

   As a result of reports from the market we have identified a possible variation in the size of the 22F mask taper connection where ...

   Waarschuwing | 07-08-2019

5. Teleflex Medical EIF-000361-01 - Hudson RCI Sheridan Endotracheal Tube (various) update

   Deze vrijwillige terugroeping is het gevolg van gemelde klachten die aangeven dat er een verhoogde incidentie is met specifieke ...

   Waarschuwing | 06-08-2019

6. Radiometer Medical ApS FAN 915-398 - AQURE system

   Radiometer has become aware that there is a potential problem relating to the AQURE System that may result in patient mix-up, ...

   Waarschuwing | 30-07-2019

7. 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

8. Uptake Medical Technology 12July2019 - InterVapor System

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

   Waarschuwing | 12-07-2019

9. High Technology Products_Cocoon Medical MEDDEV2.12_HTP_02 - Cooltech

   Paradoxical adipose hyperplasia has been included in the latest version of the cooltech's User Manual with reference number ...

   Waarschuwing | 10-07-2019

10. 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