FDA Device recall Z-0081-2022
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
- FDA Device
- Class II
- ongoing
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A 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-0081-2022 |
| 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 HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Reason
Customers were not notified of previous recalls associated with various defibrillator models.
Identifiers
| code_info | Affected serial numbers for Model # M5066A: A11K-03264, A07A-01278, B07F-01268, A10G-05443, A06E-00929, A06L-01867, A0…Affected serial numbers for Model # M5066A: A11K-03264, A07A-01278, B07F-01268, A10G-05443, A06E-00929, A06L-01867, A06L-01678, A07J-05837, A10C-03623, M5066A-ABD, A07K-02685, A09H-03908, 0205142344, Expansion - additional serial numbers for Model # M5066A: A11K-08837, Affected Serial numbers for Model # M5067A: A06K-02421. |
|---|
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-0081-2022%22
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