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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device x-ray controls - fluoroscopic
Definition A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating x-ray images and presenting them simultaneously and continuously as visible images.
Product CodeRCA
Device Class Not Classified

MDR Year MDR Reports MDR Events
2019 1 1
2020 4 4
2021 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 8 8

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