Events

Retiro De Equipo (Recall) de AIRO Mobile CT ScannerModel Number: MobiCT-32

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00924-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00924-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / 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