Events

Rappel de VMX 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 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
    63322
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-01-16
  • 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
    Ge healthcare has become aware of an issue associated with the base casting for the articulated arm of the vmx and vmx plus mobile x-ray systems that may impact operator or patient safety. the casting which retains the articulated arm to the base of the vmx may develop fatigue cracks through long term use of the product. if the casting develops cracks of significant size the articulated arm may no longer be properly secured to the base of the vmx. the loss of retention may permit the articulated arm x-ray tube and collimator to fall in an uncontrolled manner. the fall of this object may create a hazard to operators and patients during transport or use of the equipment.

Device

VMX MOBILE X-RAY SYSTEM
  • Modèle / numéro de série
    Model Catalog: 45296477 (Lot serial: All); Model Catalog: S20201SD (Lot serial: All); Model Catalog: 45296350 (Lot serial: All)
  • Description du dispositif
    VMX Mobile X-ray System
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)