FDA-Device2023-11-08Class II
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
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
237 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2024Don't want to check this manually?
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