Carestream DRX-Revolution Mobile X-Ray System — Class II medical device recall Z-1138-2017
Terminated recall by Carestream Health Inc, reported 2017-02-15, distributed nationwide. The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the bra
| Recall number | Z-1138-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc, Rochester, NY, United States |
| Recall initiated | 2017-01-12 |
| Classified | 2017-02-03 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-06-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, DE, DK, DO, ES, FI, FR, GB, GH, IE, IL, IN, IR, IT, JP, KR, KW, LB, MA, MX, MY, NL, NO, NZ, OM, PE, PL, PT, QA, RU, SA, SE, SG, TH, TR, TW |
| Serial numbers | 101, 2545 |
| Model numbers | 1019397, 1060177, DRXR-1 |
Product
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Reason for recall
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
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-1138-2017. 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.