# FDA recall Z-0289-2024

> **Carestream Health, Inc.** · Class II · device recall initiated 2023-10-02.

## Product

The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.

## Reason for recall

There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-0289-2024
- **Recalling firm:** Carestream Health, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-02
- **Report date:** 2023-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2024

## Citation

> AI Analytics. FDA recall Z-0289-2024. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0289-2024. Source: US FDA. Licensed CC0.

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