Siemens recalls specific myNeedle Guide software licenses for CT systems due to swapped orientation labels in axial slices, which may cause misalignment during procedures. Affected models include SOMATOM go.Now, go.Up, go.All, and others with listed serial numbers and UDI codes.
In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
Siemens is recalling certain myNeedle Guide software licenses for CT scanners because the labels for head, center, and feet in axial slices are swapped. This could lead to incorrect positioning during medical procedures, potentially causing misdiagnosis or treatment errors.
The software incorrectly swaps the orientation labels (head, center, feet) in axial thick slice segments. This could result in misaligned imaging data, potentially leading to inaccurate measurements or misdiagnosis during procedures. However, the issue does not cause physical harm or immediate safety risks.
Users of the recalled software licenses on Siemens CT scanners, particularly medical professionals performing imaging procedures. The risk is low as the software issue does not cause immediate harm but may affect accuracy in specific scans.
Check if your CT scanner model is listed as SOMATOM go.Now, go.Up, go.All, or go.Top with specific serial numbers (e.g., 112285, 112443) or Unique Device Identifiers (UDIs) like 04056869151571.
Verify if your CT scanner has the recalled myNeedle Guide software licenses by checking the model and serial numbers listed in the recall notice.
The affected software licenses are myNeedle Guide 2D, myNeedle Guide 2D AWP only Workflow, and myNeedle Guide 3D licenses.
SOMATOM go.Now, go.Up, go.All, go.Top, and X.cite/X.ceed models with specific serial numbers and UDI codes listed in the recall notice.
The recall notice does not specify a remedy, so users should check if their software version is affected and contact Siemens for further guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1003-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1003-2023 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.
