FDA-Device2020-09-02Class II
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Siemens Medical Solutions USA, Inc
Hazard
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
Sold states
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Affected count
329 units in total
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2888-2020Don't want to check this manually?
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