Panda iRes Infant Radiant Warmer — Class II medical device recall Z-0482-2019
Terminated recall by GE Healthcare, LLC, reported 2018-11-28, distributed nationwide. Potential electric leakage affecting the user.
| Recall number | Z-0482-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-09-25 |
| Classified | 2018-11-19 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2020-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DZ, ES, FI, FR, GB, HN, ID, IE, IN, IT, JP, KR, LT, MX, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| Quantity | 1,724 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 06036811170209, 06064511160725, 06124911170516, 06126311170516, 07041111180413, 07064411180518, 07070111180529, 07071411180530, 07112711180711 |
| Serial numbers | M1112198-164657, M1112198-526395 |
Product
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Reason for recall
Potential electric leakage affecting the user.
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-0482-2019. 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.