Events

Retiro De Equipo (Recall) de PRN 50-M+ Digital Writer

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-2016-RN-00149-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-08
  • 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-2016-RN-00149-1
  • 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
    The manufacturer has recently become aware of a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. there is an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the prn 50-m+ digital writer to meet its intended flammability and fluid ingress rating.
  • Acción
    GE Healthcare is replacing all affected printers with unaffected units. This action has been closed-out on 22/02/2017.

Device

PRN 50-M+ Digital Writer
  • Modelo / Serial
    PRN 50-M+ Digital Writer Part Number: 600-23310-01 Units manufactured from May 28, 2013 through to April 7, 2015Serial Numbers: 1801405 through 1918761ARTG Number: 117497
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd