Events

Rappel de Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003 Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty Ltd.

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
    RC-2013-RN-00629-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00629-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Ge healthcare (hc) has recently became aware of an incident in the united states, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 where the equipment fell onto the patient during the scan. gehc was permitted access to the equipment on 17 june 2013 and investigation is ongoing. as a result, gehc has not been able to determine the root cause of this incident.
  • Action
    GE Healthcare recommends that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to the schedule provided in customer documentation. Customers are asked to review safety chapter sections with appropriate personnel to ensure proper operation of the equipment. GE Healthcare is working in conjunction with the TGA for a complete investigation into the incident and will undertake any further action if required.

Device

Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, ma...
  • Modèle / numéro de série
    Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd)Multiple products affectedARTG number: 200439
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd