Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartStart MRx Monitor/Defibrillator Recalled by Philips Medical Systems, Inc. Due to Device may malfunction, which could cause therapy to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems, Inc. directly.
Affected Products
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Quantity: 74,499 devices
Why Was This Recalled?
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Medical Systems, Inc.
Philips Medical Systems, Inc. has 65 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report