FDA Device recall Z-0078-2022
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
- FDA Device
- Class II
- ongoing
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A by Philips North America, citing customers were not notified of previous recalls associated with various defibrillator models.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0078-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-09 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, WA |
Product
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Reason
Customers were not notified of previous recalls associated with various defibrillator models.
Identifiers
| code_info | Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2022%22
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