Powerheart¿ G5 Automatic AED — Class II medical device recall Z-1938-2019
Terminated recall by Cardiac Science Corporation, reported 2019-07-10, distributed in GA, TX, WI. Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the dev
| Recall number | Z-1938-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Science Corporation, Deerfield, WI, United States |
| Recall initiated | 2019-06-04 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2021-11-15 |
| Distributed | GA, TX, WI |
| Quantity | 5 devices |
| UPC / GTIN / UDI-DI | 00812394021222 |
| Serial numbers | D00000133922, D00000133927, D00000133930, D00000133934, D00000133936 |
| Model numbers | 80A, G5A |
Product
Powerheart¿ G5 Automatic AED
Reason for recall
Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
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-1938-2019. 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.