Siemens Medical Solutions USA, Inc recalls SOMATOM X.ceed Software applications: syngo.CT Brain Quan
Recalled Product
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Hazard / Issue
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;
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