Events

Recall of HEARTSTART MRX DEFIBRILLATOR/MONITOR - Q-CPR

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
    48500
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-25
  • 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 is sending this letter as a formal notice of a medical device labeling correction: -to ensure heartstart mrx customers have access to the heartstart mrx addendum as a supplement to the mrx instructions for use (ifu) -to ensure heartstart fr3 customers whose q-cpr meters are used on an mrx are aware that certain information contained in the fr3 aed instructions for administrators (ifa) and the fr3 q-cpr meter instructions for use (ifu) also applies to use of the q-cpr meters with the mrx.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR - Q-CPR
  • Model / Serial
    Model Catalog: M4761A (Lot serial: ALL); Model Catalog: 453564145481 (Lot serial: ALL); Model Catalog: 861444 (Lot serial: ALL); Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL)
  • Product Description
    HEARTSTART MRX DEFIBRILLATOR/MONITOR- Q-CPR;QCPR - CPR METER;QCPR - CPR METER UPGRADE KIT;HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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