Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A 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/Defibrillators Models: M3535A and M3536A
Brand
Philips Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: US00101159 US00322848 US00326834 US00328432 US00328439 US00328442 US00328443 US00328446 US00328450 US00328461 US00328464 US00328465 US00328468 US00328473 US00328478 US00330393 US00533518 US00533521 through US00535118 US00539526 US00540124 US00543102 US00543104 US00543138 US00543158 US00543161 US00543166 US00543167 US00543187 US00543204 US00543223 US00543239 US00546804
Philips Medical Systems, Inc. is recalling Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A due to 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connec. 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
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
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