DRX- Revolution — Class II medical device recall Z-0179-2014
Terminated recall by Carestream Health Inc., reported 2013-11-13, distributed nationwide. Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software pa
| Recall number | Z-0179-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc., Rochester, NY, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2013-11-07 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2016-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 190 units |
| Reason classes | software |
| Model numbers | 101937, 1023415, 1023423, DRXR-1 |
Product
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
Reason for recall
Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
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-0179-2014. 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.