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Sources: EU EUDAMED, US FDA
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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.
FDA Recall
Open, Classified
·Carestream Health, Inc.·Product code IZL·October 2, 2023
DRX Revolution Mobile X-Ray System
FDA Recall
Open, Classified
·Carestream Health, Inc.·Product code IZL·October 2, 2023
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
FDA Recall
Open, Classified
·Carestream Health, Inc.·Product code KPR·January 30, 2023