Events

Recall of HeartStart MRx and FR3

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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
    RC-2018-RN-00136-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00136-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Philips is sending formal notice of a medical device labeling correction to ensure the following:-heartstart mrx customers have access to the heartstart mrx addendum as a supplement to the mrx instructions for use (ifu)-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-cp meters with the mrx.
  • Action
    In August 2015, Philips distributed a Q-CPR Addendum to the MRx Instructions for Use (IFU). This information was already available in the HeartStart FR3 Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) - this was undertaken under RC-2015-RN-00832-1. Philips is requesting MRx users ensure that their copy of the MRx IFU contains the Addendum. For FR3 customers, ensure that the IFU for any MRx with which your Q-CPR Meter may be used contains the Addendum

Device

HeartStart MRx and FR3
  • Model / Serial
    HeartStart MRx and FR3 HeartStart FR3Model Number 861388 and 861389 Q-CPR Model Number 989803149941ARTG: 280486HeartStart MRxModel Number M3535A and M3536A Q-CPR Model Numbers: 453564145481, 453564257691, 989803162401 and M4761AARTG: 95661 and 261352 (both restricted to no longer include this product)Q-CPR MeterARTG: 213197
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA