Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Meditech Systems Asia Pacific Pty, ULTRASOUND PROBE COVER

   Meditech Systems Asia Pacific Pty Ltd, is conducting a Hospital Level Recall, after becoming aware that the above product may be ...

   Waarschuwing | 15-05-2017

2. Field Safety Notice: Medtronic (Covidien); Polysorb™, Endo Stitch™, Maxon™, Biosyn™ hechting

   Deze brief dient om u te informeren over het feit dat Medtronic specifieke productcodes en lotnummers van Polysorb™ gevlochten ...

   Waarschuwing | 12-05-2017

3. Field Safety Notice: Covidien LLC, Medtronic, Endo Peanut 5 mm Device

   This Field Safety Corrective Action (FSCA) is being conducted following reports that the cotton tip of the device may disengage ...

   Waarschuwing | 12-05-2017

4. Field Safety Notice: St. Jude Medical (now Abbott), Nanostim™ Leadless Pacemaker

   With this approval, we will be able to restart Nanostim implants within the Leadless Observational Study at selected sites upon ...

   Waarschuwing | 11-05-2017

5. Field Safety Notice: Roche Diagnostics, cobas® MPX Test, CE-IVD, cobas® DPX Test, CE-IVD

   Under specific conditions, there is a possibility that Target specific results sent to a customer’s LIS may not match those ...

   Waarschuwing | 10-05-2017

6. Field Safety Notice: ArcRoyal, Inflation Device 30ATM

   ArcRoyal has been informed by Perouse Medical, the manufacturer of the Inflation Device 30ATM, of a potential defect in the ...

   Waarschuwing | 08-05-2017

7. Field Safety Notice: Leica Microsystems, Leica M525 F40

   Our Quality Management process has identified that instructions for use and warnings are not always followed by the the users of ...

   Waarschuwing | 05-05-2017

8. Field Safety Notice: ALBA Bioscience, Quotient, ALBAclone® Advanced Partial RhD Typing Kit

   Performance data for component L (Anti-D LHM57/17) of the lot listed above has indicated deterioration in potency. Fabrikant: ...

   Waarschuwing | 05-05-2017

9. Field Safety Notice: Beckman Coulter, UniCel DxH 800 en 600 Coulter Cellular Analysis System

   There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood ...

   Waarschuwing | 03-05-2017

10. Field Safety Notice: LivaNova Deutschland GmbH, Heater Cooler 3T

    LivaNova is issuing an updated Field Safety Notice to inform users about the retrofit of their Heater Cooler 3T devices. ...

    Waarschuwing | 03-05-2017