Events

Retiro De Equipo (Recall) de GE Medical Nuclear Medicine System, Gamma Camera, Stationary

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 Functional Imaging Haifa.

¿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
    20041
  • Fecha de inicio del evento
    2016-04-20
  • 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 has updated the service manuals for the lightspeed ct and discovery nm to update an incorrect torque value. we are asking our customers to ensure that the organization that services their equipment uses the latest version of the service manual to maintain the safe and proper performance of the medical device. customers can continue to use the devices.
  • Acción
    Software to be upgraded

Device

GE Medical Nuclear Medicine System, Gamma Camera, Stationary

Manufacturer

GE Medical Systems Functional Imaging Haifa