Model note · X-ray

Carestream DRX-Revolution Mobile X-ray System

Name: Carestream DRX-Revolution Mobile X-ray System
Brand: Carestream DRX-Revolution

The DRX-Revolution is a Carestream mobile digital X-ray unit for bedside exams on adults and children anywhere in the hospital. It has a 32 kW generator, a Toshiba XRR-3336X tube, a tube head with multiple axes of movement, a manoeuvrable drive, touchscreens, ImageView acquisition software, and DRX Plus or Lux 35 detectors. The 2024 clearance (K241505) moved it to ImageView 2.0 and added the Lux 35 detector and Smart Noise Cancellation. For engineers the mechanical and drive history matters most: tube and boom bolts that could break, a unit that did not stop when braked and hit a lift, and a 2023 generator component failure on 2,402 systems that could overheat and smoke.

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The model

Maker, model and type.

Maker: Carestream Health, Inc.
Model: DRX-Revolution Mobile X-ray System (DRXR-1)
Device type: X-ray
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
FDA classification and clearances	Mobile X-ray system, 21 CFR 892.1720, Class II, product code IZL; K120062 (2012), K191025 (2019), K241505 (10 December 2024), K253185 (2026)	Source
Generator and tube	Carestream generator rated 32 kW; X-ray tube Toshiba XRR-3336X; collimator in the tube head	Source
Detectors	DRX Plus 3543C, DRX Plus 4343C, DRX Plus 2530C, and Lux 35 (from 2024)	Source
Software	ImageView 2.0 with Eclipse II image processing and Smart Noise Cancellation; worklist, generator control, acquisition, review, and links to HIS, RIS, PACS and printers	Source
Use	Radiographic exams on all pediatric and adult patients in all patient treatment areas	Source
Catalogue numbers in recalls	Model DRXR-1; catalogue 1019397, 1023415, 1023423	Source

Recalls

Known FDA recalls.

Z-0289-20242023-10-02
Generator electrical component failure can cause thermal overload, noise, smell and smoke (2,402 systems).
FDA record
Z-2651-20172017-05-25
Four screws missing in the tube and yoke assembly on one unit.
FDA record
Z-1138-20172017-01-12
Unit could not be stopped when braking and crashed into a lift.
FDA record
Z-0800-20152014-11-25
Bolts securing the tube assembly and boom may break (629 units).
FDA record
Z-0491-20142013-08-29
Processed images not found, leading to patient re-exposure.
FDA record
Z-0126-20142013-06-06
Power plug could spark and become warm.
FDA record

Safety

Safety warnings from the record.

A heavy motorised cart that does not stop is a crush and collision hazard; staff must know the emergency stop and the brake behaviour. Source
Two patients were re-exposed when processed images could not be found in the system (2013); confirm images reach PACS before repeating an exposure. Source

Sources

Where this note comes from.

Not covered: The user and service manuals were not read, so kV and mAs ranges, battery capacity, drive speed, weight and error codes are not included.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

X-ray