Events

Retiro De Equipo (Recall) de GE Infinia Nuclear Medicine 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 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
    14856
  • Fecha de inicio del evento
    2013-06-19
  • 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
    Following an incident at a medical centre in the united states a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 system. the cause of the incident is under investigation. users are recommended to ensure;, 1/ only qualified service personnel maintain the equipment, 2/ that preventative maintenance procedures are conducted according to the documented schedule, 3/ all users re-review the safety chapter sections of the system manual.
  • Acción
    Manufacturer to issue advice regarding use

Device

GE Infinia Nuclear Medicine Systems

Manufacturer

GE Medical Systems Functional Imaging Haifa