Events

Recall of GIRAFFE T-PIECE INFANT RESUSCITATION SYSTEM

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
    88696
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-19
  • 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 recently become aware of a potential safety issue wherein the oxygen and air wall or tank inlet fittings on the back panel were reversed during assembly. as a result this may potentially have reversed air/oxygen gas concentrations for example a setting of 100% oxygen could have an output of 21% oxygen and vice versa. the settings of the blender knob will no longer be accurate.

Device

GIRAFFE T-PIECE INFANT RESUSCITATION SYSTEM
  • Model / Serial
    Model Catalog: M1241420 (Lot serial: > 100 numbers contact mfg); Model Catalog: M1241589 (Lot serial: > 100 numbers contact mfg); Model Catalog: M1112198 (Lot serial: > 100 numbers contact mfg); Model Catalog: M1118179 (Lot serial: > 100 numbers contact mfg)
  • Product Description
    GIRAFFE T-PIECE INFANT RESUSCITATION SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC