Class I recall: HeartStart MRx defibrillator by Philips Electronics


Philips is recalling the HeartStart MRx defibrillator due to a defect in the device’s gas discharge tube. The gas discharge tube has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.

As a result of this gas discharge tube defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic operational check outlined in the device’s instructions for use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.

However, the HeartStart MRx will continue to work in “Manual” mode after AED mode failure, though the electrocardiogram displayed on the device will be noisy, which may make provider interpretation difficult.

The effected model/item numbers are M3535A, M3536A and were manufactured from September 22, 2016 to October 31, 2016. They were distributed from September 26, 2016 until November 2, 2016.

The Philips HeartStart MRx Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient’s heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down.

The HeartStart MRx monitor/defibrillator is intended for use by or on the order of a physician, and should only be administered by medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.


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