FDA Device recall Z-0204-2016
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A by Philips Medical Systems, citing 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and wit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0204-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-19 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Reason
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
Identifiers
| code_info | Serial Numbers: US00101159 US00322848 US00326834 US00328432 US00328439 US00328442 US00328443 US00328446 US0032…Serial Numbers: US00101159 US00322848 US00326834 US00328432 US00328439 US00328442 US00328443 US00328446 US00328450 US00328461 US00328464 US00328465 US00328468 US00328473 US00328478 US00330393 US00533518 US00533521 through US00535118 US00539526 US00540124 US00543102 US00543104 US00543138 US00543158 US00543161 US00543166 US00543167 US00543187 US00543204 US00543223 US00543239 US00546804 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0204-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.