FDA-Device2019-11-27Class II
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Hazard
SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
Sold states
US in the states of: GA, IN, MO, MS, NJ, OH, PA
Affected count
14 US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0265-2020More Siemens Medical Solutions USA, Inc recalls
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