Events

Retiro De Equipo (Recall) de GE Lightspeed CT Scanners with MDAS 16 5V power supply

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 Medical Systems LLC.

¿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
    18950
  • Fecha de inicio del evento
    2015-08-03
  • 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
    Ge healthcare has become aware that the service procedure used to replace 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 have been over-torqued when the component was replaced since installation. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled.
  • Acción
    Manufacturer to issue advice regarding use

Device

GE Lightspeed CT Scanners with MDAS 16 5V power supply
  • Modelo / Serial
    Model: LightSpeed Ultra, LightSpeed Plus, LightSpeed QX/i, LightSpeed 16, Affected: Manufactured from 2003-2006
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC