Events

Recall of HEARTSTART XL

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
    35521
  • Event Risk Class
    II
  • Event Initiated Date
    2007-06-21
  • 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
    In small number of devices shipped in may 2007 the ecg signal may become unusable impacting the ability to assess patient condition and the need for therapy. this is due to a component defect.

Device

HEARTSTART XL
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    HEARTSTART XL MONITOR/DEFIBRILLATOR
  • Manufacturer
    PHILIPS MEDICAL SYSTEMS

Manufacturer

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