Events

Retiro De Equipo (Recall) de PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension

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-2015-RN-00050-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-19
  • 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-00050-1
  • 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
    Maquet received complaints of grinding on double (2 arms) or triple suspensions (3 arms), with paint possibly chipping from the junction between the 2 arms.Paint chips or particles can fall down from the suspended lights. this may happen during surgical procedures, in which case, paint chips may fall inside the surgical field of a patient.
  • Acción
    A Maquet technical specialist will arrange to inspect all potentially affected devices. Where grinding arms are detected a replacement of the suspension will be provided. This action has been closed-out on 05/09/2016.

Device

PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension
  • Modelo / Serial
    PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling SuspensionUnits manufactured between March 2012 and July 2014ARTG Number: 162037
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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