Events

Retiro De Equipo (Recall) de GIRAFFE EXAM LIGHT

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
    77819
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-23
  • 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
    Ge healthcare has become aware of a potential safety issue where certain power cords could overheat. the affected power cords were manufactured by electri-cord and are referred to as "taller bridge" power cords. the overheating of the power cord could result in fire charring smoke or sparking where the power cord connects to the wall outlet which could cause thermal injury. there have been no injuries reported as a result of this issue.

Device

GIRAFFE EXAM LIGHT
  • Modelo / Serial
    Model Catalog: N/A - EXAM LIGHT ONLY (Lot serial: ALL); Model Catalog: 3400 (Lot serial: ALL); Model Catalog: 6600-0427-900 (Lot serial: ALL); Model Catalog: 3500 (Lot serial: ALL); Model Catalog: 4400 (Lot serial: ALL); Model Catalog: 3300 (Lot serial: ALL); Model Catalog: 6600-0845-800 (Lot serial: ALL); Model Catalog: 4000 ACCESS (Lot serial: ALL); Model Catalog: OMNIBED (Lot serial: ALL); Model Catalog: 120 VOLT (Lot serial: ALL)
  • Descripción del producto
    GIRAFFE EXAM LIGHT;INFANT WARMER SYSTEM;Ohmeda Medical Panda Baby Warmer;Giraffe Spot PT Lite Phototherapy System;Care Plus Incubator;GIRAFFE OMNIBED;GIRAFFE INCUBATOR
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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