Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A Recalled by Philips Medical Systems, Inc. Due to MRx Defib can be susceptible to one or...
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
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 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: 27,918 units
Why Was This Recalled?
MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
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