DRX-Revolution Mobile X-Ray System — Class II medical device recall Z-0800-2015
Terminated recall by Carestream Health Inc, reported 2014-12-24, distributed nationwide. While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembl
| Recall number | Z-0800-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc, Rochester, NY, United States |
| Recall initiated | 2014-11-25 |
| Classified | 2014-12-12 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2016-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CL, CN, DE, DK, ES, FI, FR, GB, IT, JP, KR, KW, MY, NL, NO, NZ, PH, PL, PT, SA, SE, SG, TH, TW, ZA |
| Reason classes | device malfunction |
| Serial numbers | 101, 764 |
| Model numbers | 1060177, DRXR-1 |
Product
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
Reason for recall
While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray
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-0800-2015. 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.