Recall Z-1653-2015 — Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
U.S. FDA — Device Enforcement · United States · 2015-03-16 · Class II
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Reported risk: The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
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