Events

Rappel de DISCOVERY NM/CT 670 SYSTEM - NM GANTRY

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
    120279
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-07-04
  • 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
    Ge healthcare became aware of an incident associated with patient death due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. gehc has been able to determine the cause of this incident. bolts securing the camera to the gantry were loose thereby stressing the support mechanism and resulting in the incident. the safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam. gehc has been able to determine the cause of this incident. bolts securing the camera to the gantry were loose thereby stressing the support mechanism and resulting in the incident. the safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam.

Device

DISCOVERY NM/CT 670 SYSTEM - NM GANTRY
  • Modèle / numéro de série
    Model Catalog: 5376204-XX (Lot serial: >10 lot numbers contact mfg); Model Catalog: H3100RC (Lot serial: 00000000022051); Model Catalog: H3000YA (Lot serial: > 10 lot numbers contact mfg); Model Catalog: H3000WC/WD (Lot serial: > 10 lot numbers contact mfg); Model Catalog: H3000WW (Lot serial: > 10 lot numbers contact mfg); Model Catalog: H3000WT (Lot serial: > 10 lot numbers contact mfg)
  • Classification du dispositif
    Radiology Devices
  • Description du dispositif
    DISCOVERY NM/CT 670 SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)