Events

Retiro De Equipo (Recall) de Head Positioning Devices

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2014-RN-00215-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-04
  • 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-2014-RN-00215-1
  • 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
    Envisen have discovered the lot number 0021351 was not aerated for the recommended amount of time after manufacturing, and is emitting an undesirable smell. the smell has been identified as polyether polyol and triethylene diamine. contact with or inhalation of triethylene diamine can pose a safety risk to patients.
  • Acción
    Device Technologies are requesting users to isolate affected stock from use. Affected stock can be returned to Device Technologies for credit.

Device

Head Positioning Devices

Manufacturer

Device Technologies Australia Pty Ltd