DRX-Revolution Mobile X-Ray System — Class II medical device recall Z-2651-2017
Terminated recall by Carestream Health Inc, reported 2017-07-05, distributed nationwide. Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process
| Recall number | Z-2651-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc, Rochester, NY, United States |
| Recall initiated | 2017-05-25 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2018-06-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CA, CH, CL, CN, CO, DO, IL, IN, JP, KR, MX, MY, NZ, PE, SG, TH, TR |
| Model numbers | 1019397, 1060177, DRXR-1 |
Product
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Reason for recall
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke 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-2651-2017. 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.