FDA Device recall Z-2157-2020
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of v…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of v… by Philips North America, citing heartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2157-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-27 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
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
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Identifiers
| code_info | Serial Numbers: US00100834 US00568320 US00101892 US00102393 US00206641 US00330166 US00207698 US00101198 US0060…Serial Numbers: US00100834 US00568320 US00101892 US00102393 US00206641 US00330166 US00207698 US00101198 US00602579 US00002011 US00101199 US00102000 US00102001 US00206119 US00206643 US00206812 US00206843 US00207050 US00210171 US00210937 US00210939 US00211096 US00211098 US00212132 US00212133 US00212134 US00213504 US00213507 US00317103 US00322662 US00327284 US00327290 US00327294 US00327796 US00327799 US00500001 US00534511 US00534512 US00534513 US00534514 US00535445 US00536360 US00536361 US00539849 US00539850 US00539851 US00539852 US00540841 US00545611 US00546914 US00546915 US00549033 US00549394 US00549396 US00549397 US00550766 US00550767 US00550768 US00550769 US00550770 US00550771 US00550966 US00551296 US00552735 US00553511 US00553520 US00553909 US00556154 US00556155 US00556380 US00556381 US00556382 US00556384 US00556385 US00556386 US00556388 US00556389 US00556390 US00556391 US00556392 US00556393 US00556394 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2157-2020%22
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