Events

Retiro De Equipo (Recall) de Vital Signs Disposable General Purpose 9 French Temperature probes

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-2012-RN-00818-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-08-10
  • 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-2012-RN-00818-3
  • 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
    The use of the disposable general purpose 9 french temperature probe for nasopharyngeal applications can create, in certain clinical conditions, a potential for severe epistaxis, which may require interventional procedures or prescription medications to properly resolve. these clinical conditions include patients treated with anticoagulants or are at risk for coagulopathy.
  • Acción
    GE Healthcare is recalling all probes and will be replacing them (or providing credit) with new sterile units solely to be used for oesophageal or rectal use and are updating the Instructions for Use (IFU).

Device

Vital Signs Disposable General Purpose 9 French Temperature probes

Manufacturer

GE Healthcare Australia Pty Ltd