DRX Revolution Mobile X-Ray System — Class II medical device recall Z-0090-2014
Terminated recall by Carestream Health, Inc., reported 2013-11-06, distributed nationwide. During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This
| Recall number | Z-0090-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2013-07-26 |
| Classified | 2013-10-31 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2016-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, FI, GB, IT |
| Reason classes | software |
| Serial numbers | 134, 152, 171, 173, 174, 200, 204, 205, 218, 222, 300, 306, 312, 349, 353, 410, 412, 445, 453, 469, 483 |
| Model numbers | 1019397, 1023415, 1023423, DRXR-1 |
Product
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Reason for recall
During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.
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-0090-2014. 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.