Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and… — Class II medical device recall Z-0204-2016
Terminated recall by Philips Medical Systems, Inc., reported 2015-11-11, distributed nationwide. 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade
| Recall number | Z-0204-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-11-19 |
| Classified | 2015-11-03 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, DE, ES, FI, FR, GB, HK, ID, IE, IL, IN, IT, JP, KR, LT, MX, NL, PH, PL, PT, QA, SA, SE, TW, ZA |
| Quantity | 1,553 units |
| Serial numbers | US00101159, US00322848, US00326834, US00328432, US00328439, US00328442, US00328443, US00328446, US00328450, US00328461, US00328464, US00328465, US00328468, US00328473, US00328478, US00330393, US00533518, US00533521 |
| Model numbers | M3535A, M3536A |
Product
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0204-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.