Events

Retiro De Equipo (Recall) de H LED and PowerLED Ambient Light Modules (Surgical light)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-00347-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-20
  • 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-00347-1
  • 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
    There is a potential risk of failure concerning the fixation of the ambient light module. it has been observed by some of the customers that one or several fixing tabs were broken, which led the module to detach, remaining attached by its wires only. the occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.
  • Acción
    All customers are asked to check if the ambient light module is correctly fixed. The procedure for this is provided with the customer letter. If any issues are detected by the customer, precautions should be taken in order to avoid the component falling and a Maquet representative should be contacted immediately in order to replace the broken ambient light module with a new one.

Device

H LED and PowerLED Ambient Light Modules (Surgical light)
  • Modelo / Serial
    H LED and PowerLED Ambient Light Modules (Surgical light)Model numbers: PWD700 and H LED 700 All lots manufactured from December 2006 to December 2012ARTG Number: 162037
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA