Events

Retiro De Equipo (Recall) de AIRO Mobile CT Scanner Model: 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-01256-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-09-29
  • 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-01256-1
  • 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
    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.
  • Acción
    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
  • Modelo / Serial
    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
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd