Events

Rappel de Ventri and Discovery NM 530c (Full body computed tomography (CT) system)

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-00075-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-01-25
  • 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-00075-1
  • 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
    During a patient unload following a scan the patient's fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
  • Action
    Users are being advised to exercise special care before and during patient unload: 1- Strictly adhere to the following operator's instructions: "Verify that patient limbs do not protrude from the table pallet. Using the hand held controller, move the table out and then down. 2- Please ensure that the patient is observed at all times per the operators instructions. GE Healthcare will install a correction to all systems to mitigate the risk.

Device

Ventri and Discovery NM 530c (Full body computed tomography (CT) system)
  • Modèle / numéro de série
    Ventri and Discovery NM 530c (Full body computed tomography (CT) system)ARTG Number: 197195
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd