Health Canada — Medical Devices · Canada · 2023-10-11 · Type II
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Reported risk: There is a potential for unexpected failure of the electrical components within the Carestream 1.0 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. Recall start date: September 20, 2023
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