Events

Retiro De Equipo (Recall) de Maquet H LED and PowerLED 700 Ambient Light Modules

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Maquet SA.

¿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
    16434
  • Fecha de inicio del evento
    2014-04-02
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Causa
    The ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. in some product models, this module is attached to the cupola through a set of 4 fixing tabs, which compose the plastic enclosure of the ambient light module. there is a potential risk of failure concerning the fixation of the module. it has been observed by some of our customers that one or several fixing tabs were broken, which led the ambient light 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
    Product to be modified

Device

Maquet H LED and PowerLED 700 Ambient Light Modules
  • Modelo / Serial
    Model: Models: HLED700, PWD700, Affected: All units manufactured between Dec-2006 and Dec-2012
  • Manufacturer
    Maquet SA

Manufacturer

Maquet SA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA