Siemens Medical Solutions recalls unapproved CT software applications that lack FDA 510(k) clearance. Affected users should check serial numbers listed in the official recall notice.
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. These software tools could pose risks if used on certain CT systems without proper regulatory clearance.
The software applications have not been cleared by the FDA for use on certain CT systems. This means they might not work safely or correctly, potentially leading to incorrect medical diagnoses.
Healthcare professionals using Siemens CT systems with the listed serial numbers are affected. Patients using these unapproved software applications may be at risk of inaccurate medical imaging results.
Check if your CT system has the serial numbers listed in the recall notice (e.g., 127226, 127156, etc.). The software includes specific names like syngo.CT Brain Quantification.
Identify if your CT system has the listed serial numbers from the recall notice.
The software applications have not received FDA 510(k) clearance for use on certain CT systems.
Check if your CT system has the listed serial numbers and contact Siemens for guidance.
The software lacks FDA approval, which could lead to inaccurate medical imaging results, but it does not pose an immediate safety risk.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1240-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1240-2026 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.
