Philips HeartStart FRx AED — Class II medical device recall Z-1271-2020
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-1271-2020 |
|---|---|
| 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 |
| Quantity | 44 units |
| Serial numbers | B13G-04020, B14H-00561, B14I-00249, B14J-00603, B15E-06814, B15E-08588, B15G-02703, B15G-03528, B15L-01146, B15L-07200, B16A-00186, B16A-00189, B16A-00235, B16C-00187, B16E-00725, B16E-01325, B16E-01403, B16E-01627, B16F-04894, B16G-05481, B16G-06056, B16J-01934, B16J-03182, B16J-03349, B16J-06377 and 19 more |
| Model numbers | 861304 |
Product
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
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-1271-2020. 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.