Events

Recall of HEARTSTART MRX DEFIBRILLATOR/MONITOR

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
    112458
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-18
  • 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 healthcare has become aware that a philips heartstart mrx monitor/defibrillator operating on battery power only that is used in-hospital or in pre-hospital environments may shutdown without warning if exposed to elevated levels of electromagnetic interference from other radio frequency (rf) energy sources and continuous repetitive power line bursts. examples of other equipment that can cause interference are other medical devices cellular products information technology equipment and radio/television transmissions. philips healthcare will be providing all affected customers with an ifu addendum titled heartstart mrx electromagnetic compatibility.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Model / Serial
    Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL)
  • Product Description
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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