Events

Rappel de DRX-REVOLUTION MOBILE X-RAY SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARESTREAM HEALTH INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    16332
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-01-04
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Carestream health has identified an issue with the drx-revolution mobile x-ray system that could result in unintended motion. carestream's investigation found that the pivot screws in the drive handle can back out and interfere with the driving mechanism. the backed out screw can interfere with operator control of the drx revolution and result in unintended motion. the investigation revealed that thread locking compound applied in the manufacturing process to secure this screw was not always applied as it should. to date carestream has found only a single system where this failure has occurred there was no resulting injury but the problem could manifest in additional units over the life of the device.

Device

DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Modèle / numéro de série
    Model Catalog: 1019397 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    DRX-REVOLUTION MOBILE X-RAY SYSTEM
  • Manufacturer
    CARESTREAM HEALTH INC.

Manufacturer

CARESTREAM HEALTH INC.
  • Adresse du fabricant
    ROCHESTER
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    HC