Events

Retiro De Equipo (Recall) de GEHC Discovery NM/CT 670 Nuclear Medicine 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-00679-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-03
  • 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-00679-1
  • 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
    Ge healthcare (hc) is aware of an incident in the united states, a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 where the equipment fell onto the patient during the scan. during the investigation, ge have identified a potentially related issue in connection with complaints reported to gehc relating to the discovery nm/ct 670 nuclear medicine system.
  • Acción
    While GE Healthcare continues the investigation, GE recommend that facilities immediately cease usage of the Discovery NM/CT system until additional precautionary actions can be performed.

Device

GEHC Discovery NM/CT 670 Nuclear Medicine System

Manufacturer

GE Healthcare Australia Pty Ltd