GE Healthcare — Class I medical device recall Z-1072-2014
Terminated recall by GE Healthcare, LLC, reported 2014-03-05, distributed nationwide. Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembl
| Recall number | Z-1072-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-10-01 |
| Classified | 2014-02-25 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2016-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, CA, CH, CN, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, ID, IE, IN, IT, KR, LT, MX, MY, NL, NO, PE, PL, RO, RU, SA, SE, TR, VE |
Product
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The 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 neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
Reason for recall
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
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-1072-2014. 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.