Events

Retiro De Equipo (Recall) de Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic 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-00462-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-18
  • 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-00462-1
  • 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 service procedure describing replacement of a power supply on the rotating side of the gantry specifies the wrong torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could be over-torqued if the component is replaced on your system. in the unlikely event that the bolts fail on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no reports of this issue.
  • Acción
    GE has updated the Service Manuals for the affected products to update an incorrect torque value and is advising users to ensure the organisation that services the affected equipment uses the latest version of the Service Manual. The latest version of the Service Manuals can be downloaded from the GE document library. This action has been closed-out on 30/01/2017.

Device

Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diag...
  • Modelo / Serial
    Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic systems)CT Scanners:LightSpeed Ultra (8-slice MDAS)LightSpeed Plus (4-slice MDAS)LightSpeed QX/i (4-slice MDAS)LightSpeed 16 (MDAS Only)PET/CT Scanners:Discovery STDiscovery LSARTG Numbers: 96044, 128982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd