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Siemens Medical Solutions USA, Inc recalls Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system design
Recalled September 2, 2020 · FDA recall Z-2887-2020 · Siemens Medical Solutions USA
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). · FDA Class II
Units
329 units in total
Sold at
US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Description
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).
Product
Cios Alpha, 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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →