Events

Retiro De Equipo (Recall) de Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare 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-2016-RN-00001-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-04
  • 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-2016-RN-00001-2
  • 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
    Ge healthcare has become aware of a potential safety issue related to the operation of the safety latch holding mechanism for the horizontal arm of the x-ray system. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. in order to encounter the hazardous situation where the x-ray tube horizontal arm falls, it would require the following condition to occur simultaneously which is highly unlikely:1) the counter weight cable system (steel cable or pulley/idler) breaks.2) the safety mechanism does not engage and hold the tube–arm there have been no incidents or injuries reported as a result of this internally found issue.
  • Acción
    GE Healthcare will correct all affected products. In the interim, users are advised to continue to use the system with caution. This action has been closed-out on 27/01/2017.

Device

Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
  • Modelo / Serial
    Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systemsAll serial numbersARTG Number: 201698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd