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Carestream Health, Inc. recalls The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology
Recalled November 15, 2023 · FDA recall Z-0289-2024 · Carestream Health
Hazard
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. · FDA Class II
Units
2402 systems
Sold at
US Nationwide. Global Distribution.
Description
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.
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.
Manufacturer(s)
Carestream Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →