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FDA-Device2026-02-11Class IIMISBRANDING

Siemens NAEOTOM Alpha.Pro CT brain software recalled for lacking FDA clearance

Siemens
FALSE CLAIMSNationwide distribution

Remove Siemens NAEOTOM brain software from your CT system

Siemens Medical Solutions USA is recalling three brain analysis software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain NAEOTOM Alpha.Pro CT systems. These applications were not cleared by the FDA before being distributed and must be removed from affected devices.

  • If your facility operates a NAEOTOM Alpha.Pro CT system, contact Siemens Medical Solutions to determine if your unit is affected
  • Remove the three named software applications from your system immediately if you have them installed
  • Contact Siemens for instructions on safe removal and any replacement software options
Hazard

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Affected count
2 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1242-2026

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