Events

Rappel de PRECISION 500D SYSTEM - FLURO CARRAGE & TOWER

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
    27344
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-12-24
  • 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
    It has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that your system has not been installed per specified installation requirements. ge healthcare is not aware of any fall of the overhead monitor suspension. however missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due to this issue. missing screws may increase the risk for the monitor to fall.

Device

PRECISION 500D SYSTEM - FLURO CARRAGE & TOWER
  • Modèle / numéro de série
    Model Catalog: S0910ZC (Lot serial: n/a); Model Catalog: S0912PB (Lot serial: n/a); Model Catalog: S14501BT (Lot serial: n/a); Model Catalog: S13001AX (Lot serial: n/a); Model Catalog: 2258627 (Lot serial: n/a)
  • Description du dispositif
    PRECISION 500D SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)