FDA Device recall Z-0079-2022
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
- FDA Device
- Class II
- ongoing
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 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-0079-2022 |
| 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 FRx + Defibrillator, Model # Model #s: 861304
Reason
Customers were not notified of previous recalls associated with various defibrillator models.
Identifiers
| code_info | Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918 |
|---|
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-0079-2022%22
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