Recall Z-1295-2019 — Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to in
U.S. FDA — Device Enforcement · United States · 2019-03-22 · Class II
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Reported risk: Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
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