Events

Retiro De Equipo (Recall) de OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017

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-2017-RN-00643-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-19
  • 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-2017-RN-00643-1
  • 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 surgery recently identified that product use labels on certain oec elite systems were missing or applied in the incorrect location on the device. the missing labels have the potential to result in users overlooking safe operating practices and exposing themselves or others to potential hazards that may lead to significant harm. to date, there have been no injuries reported because of this issue.
  • Acción
    Users are advised they may continue to use the OEC Elite system and to consult the Operator Manual regarding safe use of the system and precautions to be taken: - before initial use of the device - when transporting or moving the system - when connecting, or disconnecting external equipment/accessories - when locking, and unlocking brakes using the brake handle or pedal - when checking/contacting electrical connectors GE Healthcare will contact users to arrange for product correction.

Device

OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017

Manufacturer

GE Healthcare Australia Pty Ltd