Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R — Class II medical device recall Z-1986-2012
Terminated recall by Philips Healthcare Inc., reported 2012-07-18, distributed in FL, IN, MA, NY, OH, TN, TX, VA. Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
| Recall number | Z-1986-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-06-20 |
| Classified | 2012-07-11 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-08-14 |
| Distributed | FL, IN, MA, NY, OH, TN, TX, VA |
| Countries outside the US | AU, HK, IN |
| Quantity | 35 units |
| Serial numbers | US00558452, US00558453, US00558493, US00558494, US00558539, US00558540, US00558546, US00558547, US00558569, US00558576, US00558584, US00558595, US00558596, US00558597, US00558615, US00558617, US00558618, US00558619, US00558620, US00558621, US00558625, US00558626, US00558627, US00558628, US00558629 and 10 more |
Product
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 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
Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
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-1986-2012. 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.