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.
Other recalls by Carestream Health
- DRX Revolution Mobile X-Ray System
FDA Device · Class II · 2023-12-13 · Carestream Health - The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consis…
FDA Device · Class II · 2023-11-15 · Carestream Health - DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid…
FDA Device · Class II · 2023-03-08 · Carestream Health - Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…
FDA Device · Class II · 2020-01-22 · Carestream Health - OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) T…
FDA Device · Class II · 2019-05-01 · Carestream Health
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2651-2017%22
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