Events

Recall of AIRO Mobile CT ScannerModel Number: MobiCT-32

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Brainlab Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00924-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00924-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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