Events

Recall of CODEMASTER DEFIBRILLATOR MONITOR

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

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
    88857
  • Event Risk Class
    II
  • Event Initiated Date
    2005-12-01
  • 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
    Voluntary correction to address a product labelling issue. the affected lot of pads has the anterior pad label and posterior pad label located in reverse which may result in reversing pad placement.

Device

CODEMASTER DEFIBRILLATOR MONITOR
  • Model / Serial
    Model Catalog: (Lot serial: Y042005-1)
  • Product Description
    M3717A HEARTSTART DEFIBRILLATOR PADS
  • Manufacturer
    PHILIPS MEDICAL SYSTEMS

Manufacturer

PHILIPS MEDICAL SYSTEMS
  • Manufacturer Address
    ANDOVER
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC