Events

Recall of OMNIBED

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
    17361
  • Event Risk Class
    II
  • Event Initiated Date
    2002-12-10
  • 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
    Manufacturer has determined that these devices under certain conditions cause leakage currents in excess of specifications as well as complaints of short life of power failure back-up battery.

Device

OMNIBED
  • Model / Serial
    Model Catalog: (Lot serial: 53000.); Model Catalog: (Lot serial: HDGFYYYYY WHERE YYYYY IS LESS); Model Catalog: (Lot serial: HDGDYYYYY HDGEYYYYY); Model Catalog: NA PWR PLUG (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: N HOODWALL IRIS (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: N HOODWALL GROMMET (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: MANUAL RH (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: GIRAFFE INCUBATOR (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: ELEVATING BASE (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: E&W PORTHOLES (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: E&W IRISES (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: 240 VOLT (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: 230 VOLT (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: 220 VOLT (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: 120 VOLT (Lot serial: HDHFYYYYY HDHFYYYYY WHERE); Model Catalog: 100 VOLT (Lot serial: HDHFYYYYY HDH
  • Product Description
    OHMEDA MEDICAL GIRAFFE OMNIBED
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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