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Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Philips Medical Systems HeartStart MRX Defibrillator/Monitor M3536A and M3535A

17 Mar 2017

Health Canada has issued a medical device safety alert concerning HeartStart MRX Defibrillator/Monitor [Model number: M3536A and M3535A; All Lots], manufactured by Philips Medical Systems.

The manufacturer has become aware of the following issues:

  • If the pins that connect the battery to the device have become damaged or full of debris, the device may not power on or may repetitively reboot.
  • When the device is unplugged from AC mains, it may enter a state where it will not charge for shock delivery or may unexpectedly cease pacing.

For details, please refer to the Health Canada website:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/62658r-eng.php

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 March 2017

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