Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Sunrise Medical - Taxi Fixation Bracket Quickie Puma 20_40_Powered Wheelchair

   Via testing, Sunrise Medical discovered a material deficiency in the taxi fixation brackets utilized on the Puma frames produced ...

   Waarschuwing | 29-08-2017

2. Sunrise Medical Logistics B.V., Elite2 XS, Elite2 Plus with Wigwag and Elite2 Foot Gas

   Via testing, Sunrise Medical discovered the S-Drive inhibit setting to cause error for throttle displacement at startup in the ...

   Waarschuwing | 29-08-2017

3. Sage Products LLC, Specific Lots of Oral Care Products

   This recall is being initiated due to the potential for cross-contamination of oral care solutions manufactured by a third party ...

   Waarschuwing | 24-08-2017

4. Field Safety Notice: EPflex - WiTrac A.S. AAA Wire

   The cm-scaling on the product, which is visible under X-Ray, was mistakenly promoted as measuring instrument. This could have led ...

   Waarschuwing | 23-06-2017

5. Field Safety Notice: Trinity Biotech - Premier Buffer B Reagent

   We are writing to inform you that we have indentified that the closed bottle stability for some bottles of Lot 6524 may be ...

   Waarschuwing | 01-06-2017

6. Field Safety Notice: Bausch + Lomb Phaco Packs: Enhanced Packaging for Needle Wrench

   We are writing to inform you of a change we are making to the phacoemulsification packs for our Bausch + Lomb Stellaris Vision ...

   Waarschuwing | 26-05-2017

7. Field Safety Notice: Philips Medical Systems, DigitalDiagnost 3.1.x

   Opnames die van de fixed detector (4343RC) komen, kunnen sporadisch onderbelicht zijn ondanks dat de opname-parameters correct ...

   Waarschuwing | 18-04-2017

8. Field Safety Notice: Protek_FMH Medical - Sterile Disposable Endocavity Needle Guide

   In two instances the disposable needle guide identified above, used for prostate biopsy, were found to have a loose tube when ...

   Waarschuwing | 17-03-2017

9. Field Safety Notice: Beldico SA, Sterile bags for organ transplantation

   Naar aanleiding van een non-conformiteit, die vastgesteld werd tijdens de productie aan de lasnaad van bepaalde zakken van het ...

   Waarschuwing | 16-02-2017

10. Novarad Corporation 1721964-2015-00001- NovaPACS

    Novarad Corporation heeft een verslag van onjuiste berekende SUV waarden kregen in d e PET/CT fusie tool. De VOi (volume van de ...

    Waarschuwing | 16-11-2015