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Lower risk Medical device recall · FDA · Published November 24, 2020

Siemens SOMATOM CT Scanners May Delay Diagnosis Due to Scan Parameter Issue

Siemens recalls specific CT scanner models due to potential scan delays and rescan needs. Affected units may require re-scanning for accurate diagnosis.

🇺🇸 FDA recall #Z-0771-2021Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer

Siemens is recalling several CT scanner models because a software issue might cause delays in diagnosis or require patients to be rescanned. This could lead to longer wait times for accurate medical results. Read more at govinfonow.com/recall/63777-siemens-somatom-ct-scanners-may-delay-diagnosis-due-to-scan.

Source Summary by GovInfoNow · govinfonow.com/recall/63777-siemens-somatom-ct-scanners-may-delay-diagnosis-due-to-scan · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0771-2021

Cite this page

“Siemens SOMATOM CT Scanners May Delay Diagnosis Due to Scan Parameter Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63777-siemens-somatom-ct-scanners-may-delay-diagnosis-due-to-scan. Based on FDA recall #Z-0771-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0771-2021%22&limit=1).

The FDA announced on November 24, 2020, that Siemens Medical Solutions USA, Inc. is recalling SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus CT scanner systems due to a software issue. The hazard involves the system failing to trigger a cancel command followed by a reload of the scan with new parameters.

How to tell if you have it

  • SOMATOM Force (Model #10742326)
  • SOMATOM Definition As (Model #8098027)
  • SOMATOM Definition Edge (Model #10590000)
  • SOMATOM Definition Flash (Model #10430603)
  • SOMATOM Drive (Model #10431700)
  • SOMATOM Confidence (Model #10590100)
  • SOMATOM Edge Plus (Model #10267000)
  • Systems with software syngo.CT VB20A_SP2

The hazard

The system does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), Siemens ARTIS icono ceiling recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include Philips Achieva 3.0T MRI Recall (August 21, 2026), Philips Incisive CT Recall (December 3, 2025), and Philips Spectral CT on Rails Software Issues recall (March 7, 2026).

How to tell if you have this one

Check for the model numbers listed: 10742326 (Force), 80980: (Definition AS), 10590000 (Definition Edge), 10430603 (Definition Flash), 10431700 (Drive), 10590100 (Confidence), 10267000 (Edge Plus). These scanners were sold with Siemens SOMATOM CT systems using software syngo.CT VB20A_SP2.

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

What to do — step by step

  1. Check Scanner Model

    Identify your scanner model number to confirm if it is affected by this recall.

  2. Contact Siemens

    Reach out to Siemens Medical Solutions USA, Inc for guidance on next steps.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Nov 24, 202012. FDA classified it Class II: Jan 9, 202123. Published in FDA’s Enforcement Report: Jan 20, 202134. FDA terminated the recall: Feb 6, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Do I need to stop using my scanner?

No, the recall does not require immediate stoppage of use. Healthcare facilities should follow the provided guidance.

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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-0771-2021 (November 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0771-2021 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