Events

Rappel de Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems.

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-2014-RN-01052-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-26
  • 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-2014-RN-01052-1
  • 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 has recently performed field actions (tga ref.: rc-2013-rn-00629-1; rc-2013-rn-00679-1; rc-2013-rn-00695-1) on ge healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry . as part of this field action, ge healthcare is updating the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners on the nuclear medicine systems.
  • Action
    GE Healthcare is advising the customers to ensure that the organization that services the equipment uses the latest version of the Service manual and the Preventative Maintenance procedure available on GE website (link provided in the customer letter)

Device

Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, ma...
  • Modèle / numéro de série
    Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems.ARTG number: 200439
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd