Events

Rappel de OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT

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
    27252
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-10-10
  • 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
    There is a potential for the system to have a technique accuracy issue which is greater than the 10% specified per the product documentation. if the user rapidly increases or decreases the mas or kv on the display the technique displayed may be one renard step off or one kv increment off from what the actual exposure delivered will be. this will only occur if the technique is adjusted more than three selections. if the user adjusts the techniques again after this rapid selection prior to exposure the display of the techniques and the actual delivered technique will be the same. these situations are not compliant with iec 60601-2-54 clause 203.6.4.3.104.6.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 5555000-4 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-3 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-6 (Lot serial: 00001027061WK9); Model Catalog: 5555000-5 (Lot serial: 00001027300WK1); Model Catalog: 5555000-5 (Lot serial: 00001027061WK9); Model Catalog: 5555000-6 (Lot serial: 00001028024WK6); Model Catalog: 5555000-5 (Lot serial: 00001028024WK6); Model Catalog: 5555000-6 (Lot serial: 00001027195WK5); Model Catalog: 5555000-5 (Lot serial: 00001027195WK5); Model Catalog: 5555000-6 (Lot serial: 00001027893WK5); Model Catalog: 5555000-5 (Lot serial: 00001027893WK5); Model Catalog: 5555000-6 (Lot serial: 00001027826WK5); Model Catalog: 5555000-5 (Lot serial: 00001027826WK5); Model Catalog: 5555000-6 (Lot serial: 00001027346WK4); Model Catalog: 5555000-5 (Lot serial: 00001027346WK4); Model Catalog: 5555000-6 (Lot serial: 00001027263WK1); Model Catalog: 5555000-5 (Lot serial: 00001027263WK1); Model Catalog: 5555000-6 (Lot serial: 00001027300WK1); Model
  • Description du dispositif
    OPTIMA XR200AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)