Siemens Medical Solutions recalls unapproved CT software applications that lack FDA 510(k) clearance. Affected users should contact Siemens for details on removal.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Siemens has recalled specific CT software applications that haven't received FDA approval. Using these unapproved software versions could pose risks to patient safety and regulatory compliance.
The software applications have not received FDA 510(k) clearance, meaning they lack regulatory approval for medical use. This could lead to potential safety issues and non-compliance with medical device standards.
Healthcare facilities using the recalled software applications on Siemens CT systems are affected. Medical staff and patients using these unapproved software versions may face compliance risks.
Check for the software names: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, or syngo.CT ASPECTS. The serial numbers listed (183047, 183051, etc.) indicate affected units.
Reach out to Siemens Medical Solutions USA, Inc for instructions on removing the unapproved software applications.
The software applications have not received FDA 510(k) clearance, meaning they lack regulatory approval for medical use.
Check for the software names: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, or syngo.CT ASPECTS. The serial numbers listed (183047, 183051, etc.) indicate affected units.
Contact Siemens Medical Solutions USA, Inc for instructions on removing the unapproved software applications.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1241-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1241-2026 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.
