Carestream Health, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Carestream Health, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-12-13FDA-DeviceClass IIDRX Revolution Mobile X-Ray System
Unexpected failure of electrical components within the CPI generator.
- 2023-11-15FDA-DeviceClass IIThe 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
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.
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