GE Healthcare — Class I medical device recall Z-1070-2014
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-1070-2014 |
|---|---|
| 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 Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
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-1070-2014. 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.