Philips HeartStart HS1 Onsite — Class II medical device recall Z-1272-2020
Terminated recall by Philips North America LLC, reported 2020-02-26, distributed in CA, CT, FL, IL, MI, MO, MS, NJ…. Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to
| Recall number | Z-1272-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America LLC, Bothell, WA, United States |
| Recall initiated | 2019-09-10 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2024-04-29 |
| Distributed | CA, CT, FL, IL, MI, MO, MS, NJ, NY, TN, TX, WA, WI |
| Countries outside the US | AR, AU, BR, CA, CH, DE, ES, FR, HK, IT, JP, KR, NL, NO, SE, TW |
| Serial numbers | A14E-01309, A14H-00385, A14H-03858, A14I-05831, A14I-06556, A14J-04548, A14J-05349, A14J-06953, A15B-02135, A15C-06311, A15F-00203, A15F-00836, A15H-01226, A15H-04421, A15I-00313, A15J-02119, A15J-03499, A16A-00020, A16A-04110, A16A-05193, A16B-01360, A16B-05332, A16D-02839, A16E-00092, A16E-00321 and 71 more |
| Model numbers | 861304, M5066A, M5068A |
Product
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Reason for recall
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1272-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.