FDA-Device2016-04-06Class II

Cios Alpha, mobile X-ray system

Siemens Medical Solutions USA, Inc
Hazard

Software issues on Cios Alpha mobile C-Arm system

Sold states
Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
Affected count
89 systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Cios Alpha, mobile X-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1278-2016

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