Events

Recall of EGM - ESSENTIAL GAS MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    49490
  • Event Risk Class
    III
  • Event Initiated Date
    2010-10-06
  • 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
    Philips intellivue g5 essential gas module (egm) may display an unusually high sample flow rate up to 420ml/min instead of 200ml/min +/-20 ml/min. this high flow rate will result in a failed zero calibration and may result in additional technical alarms (inops) and in the display of a question mark <-?-> instead of a numeric value for the measured gases.

Device

EGM - ESSENTIAL GAS MODULE
  • Model / Serial
    Model Catalog: G5 M1019A (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    EGM - ESSENTIAL GAS MODULE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC