Philips HeartStart MRx Defibrillators Recalled for Potential Shutdown
Philips is recalling HeartStart MRx monitor/defibrillators because they may shut down without warning if exposed to elevated electromagnetic interference.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a life-saving medical device that may fail to function during a critical emergency due to environmental interference, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 64,972 units of the HeartStart MRx Monitor/Defibrillator. The affected models include M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, and M3536M6. These devices are used by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.
The recall is due to a risk that the device may shut down without warning if it is operating on battery power and is exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources. The affected serial numbers range from US00100100 to US00210461.
The devices were distributed nationwide in the United States and internationally to numerous countries. Users should contact Philips Medical Systems for instructions on how to address the issue.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personn
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 64,972
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers ranging: From US00100100 to US00210461
Distribution
Related recalls
Same manufacturer · Philips Medical Systems, Inc.
See all →- ModeratePhilips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- ModeratePhilips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- SeverePhilips IntelliVue Information Center iX Software Recall for Alarm Failure
FDA (Devices) · 2015-12-16
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- HighPhilips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
FDA (Devices) · 2015-12-09
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12