HeartStart MRx Monitor/Defibrillator — Class II medical device recall Z-2035-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-06-06, distributed in NC, OH. The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been lo
| Recall number | Z-2035-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2018-05-03 |
| Classified | 2018-05-30 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2019-10-17 |
| Distributed | NC, OH |
| Countries outside the US | LB |
| Quantity | 5 |
| Model numbers | M3535A |
Product
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) 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
The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.
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-2035-2018. 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.