Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and… — Class II medical device recall Z-1194-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-03-19, distributed nationwide. When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly d
| Recall number | Z-1194-2014 |
|---|---|
| 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 | 2014-02-18 |
| Classified | 2014-03-12 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2020-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, AW, BE, BR, CA, CH, CN, DE, EC, EG, ES, FI, FR, GB, HK, ID, IE, IL, IN, IT, KE, KR, KW, LV, MA, MX, MY, NL, NO, OM, PH, PK, PL, QA, SA, SE, SG, TH, TR, TW, UA, ZA |
| Quantity | 6,583 units |
| Model numbers | M3535A, M3536A |
Product
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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
When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
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-1194-2014. 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.