MRx Defibrillator Model # M3535A & M3536A — Class I medical device recall Z-0489-2018
Terminated recall by Philips North America, LLC, reported 2018-02-14. Affected units may have a defective component that is intended to protect the internal circuitry from high vol
| Recall number | Z-0489-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2017-07-12 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-05-27 |
| Countries outside the US | GB, IE, IN, JP, KR, MX, MY, ZA |
| Quantity | 71 units |
| UPC / GTIN / UDI-DI | 00884838000018 |
| Serial numbers | US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241 and 46 more |
| Model numbers | M3535A, M3536A |
Product
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
Reason for recall
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.
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-0489-2018. 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.