Philips Medical Systems, Inc. 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 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Philips Medical Systems, Inc.
Lot Codes / Batch Numbers
Model M3535A: US00100100 to US00552845, Model M3536A: US00100902 to US00552848, Model M3536M: US00500002 to US00501201, Model M3536MC: US00500001 to US00500087, Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679
Products Sold
Model M3535A: US00100100 to US00552845; Model M3536A: US00100902 to US00552848; Model M3536M: US00500002 to US00501201; Model M3536MC: US00500001 to US00500087; Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679; Model M3536M5: US00500001 to US00552801 Note: Not every serial number within the listed ranges are affected by this Medical Device Correction. Philips HeartStart MRx Monitors/Defibrillators (1) within the identified serial number range AND (2) meeting one or both of the conditions below are affected by the issue. Condition #1: Device has EtCO2 Option. Devices with the EtCO2 option are affected. To determine if an MRx has the EtCO2 option, press the Menu Select button to open the Main Menu. Use the Navigation and Menu Select buttons to select Other, followed by Print Device Info. Devices with EtCO2 option have etCO2 printed under Options on the printed strip. Condition #2: Device has Old Cap Plate. Devices with a paddle tray or the new cap plate are not affected. New Cap Plate (NOT affected) positions the handle in the middle of the cap plate and covers the entire top of the MRx.
Philips Medical Systems, Inc. is recalling Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536 due to 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/D. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026