Events

Rappel de AIRO Mobile CT ScannerModel Number: MobiCT-32

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab 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-2017-RN-00924-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-07
  • 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-2017-RN-00924-1
  • 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
    Mobius imaging has identified an issue with the configuration settings of the main-drive motion controller on specific airo mobile ct scanners. if a main-drive motor has a broken encoder or sensor wire there is a risk of unintended motion while driving or transporting the airo system. the routing of the main-drive motor cable can cause long-term repeated bending & flexing of the cable and possible breakage of the motor wire(s) while the system goes into / out of transport mode and while driving or transporting the system. if a wire were to break, the main-drive motor would not get the correct feedback and the motor could behave unpredictably.
  • Action
    Review the supplied information and attach the warning label provided to the machine as per the instructions in the Customer Letter.

Device

AIRO Mobile CT ScannerModel Number: MobiCT-32
  • Modèle / numéro de série
    AIRO Mobile CT ScannerModel Number: MobiCT-32Catalogue Number: 2017-FSCA-001Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146 and AIRO-0149ARTG Number: 223542
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd