FDA-Device2026-02-11Class IIMISBRANDING
Siemens SOMATOM X.ceed CT scanner 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 SOMATOM X.ceed CT scanners because these applications were not cleared by the FDA before being distributed. Two CT systems are affected worldwide.
- If your facility operates a SOMATOM X.ceed CT system, contact Siemens Medical Solutions to verify if your system is affected using serial numbers 125205 or 125250
- Follow Siemens' instructions to remove the three software applications from your system
- Do not use the affected software applications for clinical diagnosis until they are cleared by the FDA or removed
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
Adults
Illnesses reported
None reported
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
SOMATOM X.ceed 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-1239-2026More Siemens recalls
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