Events

Retiro De Equipo (Recall) de Maquet Operating Theatre Lights

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
    18013
  • Fecha de inicio del evento
    2015-02-04
  • 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
    Maquet has received some complaints of grinding on double (2 arms) or triple suspensions (3 arms), with paint possibly chipping from the junction between 2 arms. paint chips or particles can fall down from the suspension. this may happen during surgical procedures and paint chips may fall inside the surgical field of a patient.
  • Acción
    Product to be modified

Device

Maquet Operating Theatre Lights
  • Modelo / Serial
    Model: PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range, Affected: Manufactured between March 2012 and July 2014
  • Manufacturer
    Maquet SA

Manufacturer

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