Events

Retiro De Equipo (Recall) de GE Proteus XR/a X-ray systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por GE Hualun Medical Systems Co 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
    16845
  • Fecha de inicio del evento
    2014-06-18
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    If a device is improperly re-installed, the collimator may not be properly seated and may loosen and fall. such an event may occur immediately following re-installation during a service maintenance activity, but may also occur a few months after a service activity and continued use. a fall of a collimator while the system is in use could result in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
  • Acción
    Product to be modified

Device

GE Proteus XR/a X-ray systems

Manufacturer

GE Hualun Medical Systems Co Ltd