Events

Recall of HEARTSTART MRX DEFIBRILLATOR/MONITOR - BATTERY/POWER 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
    120321
  • Event Risk Class
    II
  • Event Initiated Date
    2010-03-09
  • 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
    After more than two (2) years of continuous use vibration or frequent connections and disconnections may cause mechanical wear which results in an intermittent electrical connection between the m3538a battery and the heartstart mrx monitor/defibrillator.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR - BATTERY/POWER MODULE
  • Model / Serial
    Model Catalog: M3538A (Lot serial: > 1000 numbers contact mfg); Model Catalog: M3536A (Lot serial: > 1000 numbers contact mfg); Model Catalog: M3535A (Lot serial: > 1000 numbers contact mfg)
  • Product Description
    HEARTSTART MRX DEFIBRILLATOR/MONITOR 14.8 VOLT LITHIUM ION BATTERY
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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