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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device c-arm fluoroscopic x-ray system
Definition Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
Product CodeRCC
Regulation Number 892.1650
Device Class 2

MDR Year MDR Reports MDR Events
2018 50 50
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 50 50

Manufacturer Recall Class Date Posted
1 Ge Healthcare II Aug-27-2020