FDA Device recall Z-0179-2014
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of DRX- Revolution, Catalog number: 101937, 1023415 & 1023423 by Carestream Health, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0179-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-29 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | US |
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
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
Identifiers
| code_info | Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0179-2014%22
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