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Lower risk Medical device recall · FDA · Published December 22, 2022

Siemens myNeedle Guide Software Recalls: Incorrect Label Order in CT Scans

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.

🇺🇸 FDA recall #Z-1003-2023Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

What happened, in plain English

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. Read more at govinfonow.com/recall/59070-siemens-myneedle-guide-software-recalls-incorrect-label-order-in-ct.

Source Summary by GovInfoNow · govinfonow.com/recall/59070-siemens-myneedle-guide-software-recalls-incorrect-label-order-in-ct · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1003-2023

Cite this page

“Siemens myNeedle Guide Software Recalls: Incorrect Label Order in CT Scans.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59070-siemens-myneedle-guide-software-recalls-incorrect-label-order-in-ct. Based on FDA recall #Z-1003-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1003-2023%22&limit=1).

Why it’s dangerous

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.

Who’s affected

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.

How to tell if you have this one

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.

  • Brand
    Siemens
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify if your CT scanner has the recalled myNeedle Guide software licenses by checking the model and serial numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Dec 22, 202212. FDA classified it Class II: Jan 20, 202323. Published in FDA’s Enforcement Report: Feb 1, 2023320222023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1003-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1003-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA