GE Healthcare Engstrom Carestation — Class II medical device recall Z-1270-2015
Terminated recall by GE Healthcare, reported 2015-03-25, distributed nationwide. Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbal
| Recall number | Z-1270-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-01-27 |
| Classified | 2015-03-13 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-02-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HN, HR, ID, IL, IN, IQ, IT, JP, KE, KR, KW, LB, LK, MA, MT, MX, MY, NL, OM, PA, PE, PL, PT, QA, RS, SA, SG, SK, SV, TH, TN, TR, UY, VE, VN, ZA |
| Serial numbers | CBCN01062, CBCN01064, CBCN01080, CBCN01102, CBCN01129, CBCN01130, CBCN01132, CBCN01133, CBCN01134, CBCN01135, CBCN01137, CBCN01138, CBCN01139, CBCN01140, CBCN01141, CBCN01142, CBCN01144, CBCN01145, CBCN01147, CBCN01149, CBCN01150, CBCN01151, CBCN01153, CBCN01155, CBCN01156 and 475 more |
| Model numbers | 1505-8538-000, 1505-9000-000, 1505-9003-000 |
Product
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Reason for recall
Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
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-1270-2015. 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.