Events

Rappel de GE Infinia Nuclear Medicine Systems

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Medical Systems Functional Imaging Haifa.

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
    14856
  • Date de mise en oeuvre de l'événement
    2013-06-19
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    Following an incident at a medical centre in the united states a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 system. the cause of the incident is under investigation. users are recommended to ensure;, 1/ only qualified service personnel maintain the equipment, 2/ that preventative maintenance procedures are conducted according to the documented schedule, 3/ all users re-review the safety chapter sections of the system manual.
  • Action
    Manufacturer to issue advice regarding use

Device

GE Infinia Nuclear Medicine Systems
  • Modèle / numéro de série
    Model: All Infinia systems manfactured from 2003 to 2013; all VG and VG Hawkeye systems manufactured from 1996 to 2003; all Helix systems manfactured from 1992 to 1996, Affected:
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Medical Systems Functional Imaging Haifa

Manufacturer

GE Medical Systems Functional Imaging Haifa