FDA Announces Medical Device Recall of HeartStart MRx Monitor/Defibrillator

April 4, 2017—On March 24, 2017, the FDA announced a recall to all healthcare providers and first responders who use the HeartStart MRx Monitor/Defibrillator. The Class I recall warns the device may not power up, charge, or deliver the expected electrical shock therapy or that it may unexpectedly stop pacing.

The FDA has provided complete details on the recall.


The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

J11008 4/17

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