Siemens Medical Solutions recalls unapproved CT software applications that lack FDA 510(k) clearance. Affected users should stop using these applications until a fix is available.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Siemens is recalling specific CT software applications that have not received FDA clearance. Using these unapproved software tools could pose risks to patient safety and medical procedures.
The software applications lack FDA 510(k) clearance, meaning they haven't been proven safe and effective for medical use. This could lead to inaccurate patient measurements or improper medical decisions if used without proper regulatory approval.
Healthcare providers using Siemens CT systems with the recalled software applications are affected. Medical staff who operate these systems may be at risk if they continue using the unapproved software.
Check for the software names: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, or syngo.CT ASPECTS. The material number 1019110:00 and serial numbers 258043 or 258055 indicate the affected units.
Immediately stop using the recalled syngo.CT software applications as they lack FDA clearance.
The software applications have not received FDA 510(k) clearance, meaning they haven't been proven safe and effective for medical use.
The affected software includes syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS.
Check for the material number 10191100 and serial numbers 258043 or 258055 on your CT system.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1242-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1242-2026 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.
