Events

Rappel de DEFINIUM AMX 700 DIGITAL MOBILE SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    65563
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-11-13
  • 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
    This recall is due to an update by ge healthcare on the preventative maintenance and cleaning procedures of the exposure switches footswitches and hand switches of x-ray systems to address aggressive disinfectant procedures used by the users. the updates include recommended replacement of console switches every three years and recommends cleaning x-ray systems with cloth moistened in warm soapy water or cleaners approved by ge.

Device

DEFINIUM AMX 700 DIGITAL MOBILE SYSTEM
  • Modèle / numéro de série
    Model Catalog: S2000PA/PB (Lot serial: n/a); Model Catalog: S0910JB (Lot serial: n/a); Model Catalog: 5555000 (Lot serial: n/a); Model Catalog: 5555000-2 (Lot serial: n/a); Model Catalog: 2258627 (Lot serial: n/a); Model Catalog: 2275938-7 (Lot serial: n/a); Model Catalog: 2236420-7 (Lot serial: n/a); Model Catalog: 5555000-5 (Lot serial: n/a); Model Catalog: 5555000-6 (Lot serial: n/a); Model Catalog: 2169360-7 (Lot serial: n/a); Model Catalog: 46-270954G1 (Lot serial: n/a); Model Catalog: 46-270157G-1 (Lot serial: n/a); Model Catalog: 2115090-12 (Lot serial: n/a); Model Catalog: 2403791 (Lot serial: n/a); Model Catalog: 5555000-4 (Lot serial: n/a); Model Catalog: 5555000-3 (Lot serial: n/a); Model Catalog: 2407576 (Lot serial: n/a); Model Catalog: 46-329267G1 (Lot serial: n/a); Model Catalog: 2115090 (Lot serial: n/a)
  • Description du dispositif
    DEFINUM AMX 700 DIGITAL MOBILE SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)