Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Q
Recalled Product
NAEOTOM Alpha.Pro 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: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;
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