GE Healthcare — Class II medical device recall Z-1285-2015
Terminated recall by GE Healthcare, reported 2015-03-25, distributed in DC, GU, PR. Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
| Recall number | Z-1285-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-02-16 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2017-06-23 |
| Distributed | DC, GU, PR |
| Countries outside the US | AR, AT, AU, BB, BD, BO, BR, CL, CN, CO, CR, DE, DO, EC, ES, FI, FR, GY, HK, ID, IE, IL, IN, JM, JP, KR, KY, MX, NI, NP, PA, PE, PH, PT, PY, RU, SG, SV, TH, TT, TW, UY, VE, VN |
| Serial numbers | 408930-001, 408930-002, SBC0162242SA, SBC05370011SA, SBC05370013SA, SBC05370017SA, SBC05370018SA, SBC05400001SA, SBC05400003SA, SBC05440023SA, SBC05440024SA, SBC05440025SA, SBC05440026SA, SBC05440028SA, SBC05440029SA, SBC05440030SA, SBC05440032SA, SBC05450034SA, SBC05450035SA, SBC05450036SA, SBC05450037SA, SBC05450038SA, SBC05450039SA, SBC05450041SA, SBC05450043SA and 475 more |
| Model numbers | 11037486SA, 2028038-008, 408930-001, 408930-002, 46SA, 8213886SA, BC07092014SA, SBC0, SBC008324223SA, SBC05200028GA, SBC05370012SA, SBC05370014SA, SBC05370015SA, SBC05370016SA, SBC05370019SA, SBC05370020SA, SBC05370021SA, SBC05370022SA, SBC05400002SA, SBC05400005SA, SBC05400006SA, SBC05440027SA, SBC05440031SA, SBC05440033SA, SBC05450040SA and 475 more |
Product
GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
Reason for recall
Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
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-1285-2015. 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.