Events

Retiro De Equipo (Recall) de POWERLED 700

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED INC..

¿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
    88856
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-03-14
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    On powerled 700 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. one or several fixing tabs may be broken which may lead 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.

Device

POWERLED 700
  • Modelo / Serial
    Model Catalog: 700 (Lot serial: NA); Model Catalog: (Lot serial: NA)
  • Descripción del producto
    POWERLED 700
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC