FDA-Device2019-05-15Class II
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 interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may
Siemens Medical Solutions USA, Inc
Hazard
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
Sold states
US Nationwide Distribution in the states of NC, MA
Affected count
2 US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
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 interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2019Don't want to check this manually?
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