Events

Retiro De Equipo (Recall) de V-Sign Sensor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Temple Healthcare 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-2015-RN-00355-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-01
  • 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-2015-RN-00355-1
  • 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
    Based on high customer complaint rates sentec has identified three production batches of v-sign sensors where the pco2-measuring element shows signs of pre-mature aging; in some cases already after 4 to 11.5 months of use resulting in loss of pco2-monitoring function.This action was undertaken prior to notifying tga.
  • Acción
    Temple Helathcare (local SenTec distributor) is contacting all the affected customers and replacing the sensor free of charge in return for the affected sensor. This action has been closed-out on 15/02/2016.

Device

V-Sign Sensor

Manufacturer

Temple Healthcare Pty Ltd