Events

Retiro De Equipo (Recall) de Ventri and Discovery NM 530c (Full body computed tomography (CT) system)

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-2013-RN-00075-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-25
  • 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-2013-RN-00075-1
  • 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
    During a patient unload following a scan the patient's fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
  • Acción
    Users are being advised to exercise special care before and during patient unload: 1- Strictly adhere to the following operator's instructions: "Verify that patient limbs do not protrude from the table pallet. Using the hand held controller, move the table out and then down. 2- Please ensure that the patient is observed at all times per the operators instructions. GE Healthcare will install a correction to all systems to mitigate the risk.

Device

Ventri and Discovery NM 530c (Full body computed tomography (CT) system)

Manufacturer

GE Healthcare Australia Pty Ltd