Stand-Alone Resuscitation Unit — Class II medical device recall Z-0915-2014
Terminated recall by GE Healthcare, reported 2014-02-12, distributed nationwide. Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patie
| Recall number | Z-0915-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Laurel, MD, United States |
| Recall initiated | 2013-12-12 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BO, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HU, ID, IE, IL, IN, IQ, IT, KR, KW, LT, MA, MX, MY, NG, NL, NO, NZ, PE, PH, PL, PT, RO, RU, SA, SE, SG, SK, TH, TN, TR, UY, VE, ZA |
| Quantity | 48 units |
| Serial numbers | 400311, 400434, 400493, 400504, 400506, 400657, 400768, 400802, 401203, 401208, 401481, 401758, 401759, 401760, 401761, 401762, 401763, 401764, 401765, 401766, 401767, 401768, 401769, 401770, 401771 and 23 more |
| Model numbers | M1139612 |
Product
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
Reason for recall
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
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-0915-2014. 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.