Device 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.
Z-2887-2020
Product summary
- Event
- Event 86166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 329 units in total
- Official record key
device-enforcement:Z-2887-2020
Official wording
Reason: 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).
Code information: Cios Alpha (VA20)- 10308191 Cios Alpha (VA30)- 11105200
Distribution pattern: US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
Derived failure modes
-
Unknown
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).