FDA-Device2023-11-08Class II
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194
Siemens Medical Solutions USA, Inc
Hazard
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
Sold states
Nationwide
Affected count
***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0196-2024Don't want to check this manually?
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