Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options… — Class II medical device recall Z-0593-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-01-08, distributed in IN, MS, TX, VA. Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrilla
| Recall number | Z-0593-2014 |
|---|---|
| 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 | 2013-06-07 |
| Classified | 2013-12-27 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2017-03-22 |
| Distributed | IN, MS, TX, VA |
| Countries outside the US | CH, DE, DK, ES, FR |
| Quantity | 93 units |
| Reason classes | labeling |
| Serial numbers | US00558442, US00558461, US00558531, US00558532, US00558615, US00558758, US00558759, US00560165, US00560166, US00560738, US00560739, US00560740, US00560745, US00560872, US00560909, US00561068, US00561209, US00561447, US00561452, US00561519, US00561578, US00562454, US00562504, US00562527, US00562640 and 9 more |
| Model numbers | M3536A |
Product
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) 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
Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled 1-10
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-0593-2014. 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.