FDA Device recall Z-2651-2017
DRX-Revolution Mobile X-Ray System
- FDA Device
- Class II
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class II recall of DRX-Revolution Mobile X-Ray System by Carestream Health, citing carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2651-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-25 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carestream Health |
| Distribution | US |
Product
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Reason
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Identifiers
| code_info | Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2651-2017%22
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