Events

Rappel de AIRO Mobile CT Scanner Model: 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-01256-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-09-29
  • 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-01256-1
  • 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
    The manufacturer, mobius imaging, believes that due to an issue with the configuration settings of the tilt-drive motion controller, if a tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended tilt motion of gantry while airo system is homing the axis at startup or preparing for a scan. since the airo is not currently monitoring for intermittent connections or broken tilt-drive motor wires, if a wire breaks or the signal becomes intermittent the tilt-drive motor would not get the correct feedback and the motor could behave unpredictably. the following behaviours could be seen in the airo: when pushing the green button to home/tilt the gantry, the gantry may tilt in either direction, and at a higher than normal speed. the operator may not be able to respond (by releasing green button or pressing the emergency stop button) in time to prevent harm. to date, there have been no injuries reported related to this issue.
  • Action
    Due to the risk of unintended (tilting) motion of the gantry, customers are advised to discontinue using the AIRO until the tilt drive motion firmware has been updated on their system. Brainlab is arranging the firmware update for installation on the affected serial numbers on 29 September 2017.

Device

AIRO Mobile CT Scanner Model: MobiCT-32
  • Modèle / numéro de série
    AIRO Mobile CT Scanner Model: MobiCT-32Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146, AIRO-0149, AIRO-0209 and AIRO-0217 ARTG Number: 223542
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd