GE Healthcare — Class I medical device recall Z-0748-2013
Terminated recall by GE Healthcare, LLC, reported 2013-02-20, distributed in AL, AZ, CA, CO, FL, GA, IA, ID…. Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembl
| Recall number | Z-0748-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-10-15 |
| Classified | 2013-02-08 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2017-01-18 |
| Distributed | AL, AZ, CA, CO, FL, GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NV, NY, OH, OR, PA, TX, VT, WA, WI, WV |
| Countries outside the US | AU, BE, CA, CH, CN, FR, GB, NZ, PL, SA |
| Quantity | 276 units |
| Model numbers | M1139417, M1192226-072951, M1192226-084200, M1192226-095181, M1192226-104599, M1223628 |
Product
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System 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.
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-0748-2013. 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.