Events

Recall of GIRAFFE EXAM LIGHT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77819
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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)
  • Product Description
    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.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC