Siemens recalls unapproved CT software applications for SOMATOM X.ceed systems that lack FDA 510(k) clearance. Affected users should contact Siemens for details.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Siemens is recalling specific software applications for its SOMATOM X.ceed CT systems because they haven't received FDA approval. This means the software could be unsafe for medical use without proper regulatory clearance.
The software applications have not been cleared by the FDA for use with CT systems. This means they might not meet safety and effectiveness standards required for medical devices, potentially leading to inaccurate results or other issues.
Healthcare facilities using the unapproved software applications on SOMATOM X.ceed CT systems are likely affected. Medical professionals using these specific software tools may be at risk if they rely on unapproved features.
Check if your SOMATOM X.ceed CT system has the software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, or syngo.CT ASPECTS. The material number 11330002 and UDI-DI 04056869231051 are also indicators.
Verify if your SOMATOM X.ceed system has the unapproved software applications listed in the recall notice.
The software applications have not received FDA 510(k) clearance, meaning they lack regulatory approval for medical use.
Look for the software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, or syngo.CT ASPECTS on your SOMATOM X.ceed CT system.
The recall does not require immediate removal; users should check the software version and contact Siemens for guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1239-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1239-2026 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
