Events

Rappel de MSK 1.5T Extreme and Optima MR430s (MRI 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-2016-RN-00652-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-13
  • 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-2016-RN-00652-1
  • 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
    A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. there have been no injuries reported as a result of this issue. at this site, a magnet heater probe connection became disconnected. this resulted in ice build-up within the magnet blocking the cryogen vent. since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.
  • Action
    GE Healthcare is advising users to notify GE Service Engineer if the Magnet Monitoring Unit (MMU) detects any abnormal or out of specification reading. If the Magnet Monitoring Unit (MMU) detects an error it will display a pop-up window on the system monitor which will be seen by the operator. MMU reported errors will be in the form of a CAS7XX error (XX being the specific error) with a brief description. If no Magnet Monitoring Unit errors are reported, there are no action is required. Users can continue normal use of the affected products. GE will be correcting all affected units. This action has been closed out on 13 Jun 2017.

Device

MSK 1.5T Extreme and Optima MR430s (MRI Systems)

Manufacturer

GE Healthcare Australia Pty Ltd