Philips HeartStart FRx AED — Class II medical device recall Z-1913-2018
Terminated recall by Philips Electronics North America Corp., reported 2018-05-30, distributed nationwide. An issue with one of the electric components (a resistor) could result in the device not delivering a shock wh
| Recall number | Z-1913-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Electronics North America Corp., Bothell, WA, United States |
| Recall initiated | 2018-03-14 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2020-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AR, AT, AU, AW, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, ID, IE, IL, IN, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RS, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 660,519 defibrillators |
Product
Philips HeartStart FRx AED.
Reason for recall
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
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-1913-2018. 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.