FDA Device recall Z-1138-2017
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) --…
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) --… by Carestream Health, citing the firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1138-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-12 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carestream Health |
| Distribution | US |
Product
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Reason
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Identifiers
| code_info | Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only) |
|---|
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-1138-2017%22
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