Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared… — Class I medical device recall Z-1846-2019
Terminated recall by GE Healthcare, LLC, reported 2019-07-17, distributed nationwide. The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if th
| Recall number | Z-1846-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-07-11 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2024-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BB, BD, BE, BG, BH, BM, BO, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 9,094 devices |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 06000511160518, 06000611180102, 06001711160520, 06002411160520, 06002711170113, 06003111160520, 06003711160524, 06004411160524, 06004711170117, 06005111160524, 06005411170117, 06006111170124, 06006511160527, 06007211160527, 06007711180209, 06007811170131, 06008311170201, 06008411160607, 06009011170201, 06010511160616, 06011211160616, 06012211160620, 06012211170223, 06013411160625, 06013911170223 and 176 more |
Product
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
Reason for recall
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
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-1846-2019. 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.