The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray… — Class II medical device recall Z-0289-2024
Ongoing recall by Carestream Health, Inc., reported 2023-11-15, distributed nationwide. There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. gen
| Recall number | Z-0289-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 2,402 systems |
| UPC / GTIN / UDI-DI | 60889971019394, 60889978618897 |
| Serial numbers | 1103, 1243, 1684, 1728, 1924, 1925, 197, 20003, 20004, 20005, 20006, 20007, 20008, 20009, 20010, 20011, 20012, 20013, 20014, 20016, 20019, 20020, 20021, 20023, 20025 and 475 more |
Product
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
Reason for recall
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
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-0289-2024. 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.