FDA-Device2026-02-11Class IIMISBRANDING
Siemens NAEOTOM Alpha CT software applications recalled for lacking FDA clearance
What this means
Siemens Medical Solutions has recalled three software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain NAEOTOM Alpha CT systems. These applications were not cleared by the FDA before being distributed, which is required for medical imaging software.
- If your facility operates a NAEOTOM Alpha CT system, check the serial number against the affected list provided by Siemens
- Contact Siemens Medical Solutions to confirm whether your unit is affected
- Follow Siemens's instructions to remove the three software applications from your system
- Do not use the three recalled applications for patient imaging or diagnosis
The agency's original wording
Hazard
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.
Affected count
88 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
NAEOTOM Alpha 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-1240-2026More Siemens recalls
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