Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
MRx Defibrillator Model # M3535A & M3536A Recalled by Philips North America, LLC Due to Affected units may have a defective component that...
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 North America, LLC directly.
Affected Products
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 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: 71 units
Why Was This Recalled?
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Where Was This Sold?
No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
About Philips North America, LLC
Philips North America, LLC has 88 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report