Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A — Class II medical device recall Z-2157-2020
Terminated recall by Philips North America, LLC, reported 2020-06-03, distributed nationwide. HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required c
| Recall number | Z-2157-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-04-27 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2021-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, GB, KR, NL, NO |
| Quantity | 260 units |
| Serial numbers | US00002011, US00100834, US00101198, US00101199, US00101290, US00101892, US00102000, US00102001, US00102393, US00205338, US00205339, US00205340, US00206119, US00206641, US00206643, US00206812, US00206843, US00207050, US00207698, US00208771, US00208773, US00209243, US00210171, US00210937, US00210939 and 235 more |
| Model numbers | M3535A, M3536A, M3536M |
Product
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Reason for recall
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
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-2157-2020. 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.