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Lower risk Medical device recall · FDA · Published December 18, 2020

Siemens ARTIS Icono X-Ray Systems with VE20B Software May Cause Procedure Errors

Siemens recalls ARTIS Icono biplane and floor systems with VE20B software due to misleading error messages and gaps in the operator manual, which may cause procedures to terminate and switch to alternative x-ray systems.

🇺🇸 FDA recall #Z-1144-2021Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer

Siemens is recalling ARTIS Icono biplane and floor systems with software version VE20B. These systems may show incorrect error messages or fail to properly manage system functions, potentially causing procedures to end and switch to another x-ray system. Read more at govinfonow.com/recall/63640-siemens-artis-icono-x-ray-systems-with-ve20b-software-may.

Source Summary by GovInfoNow · govinfonow.com/recall/63640-siemens-artis-icono-x-ray-systems-with-ve20b-software-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1144-2021

Cite this page

“Siemens ARTIS Icono X-Ray Systems with VE20B Software May Cause Procedure Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63640-siemens-artis-icono-x-ray-systems-with-ve20b-software-may. Based on FDA recall #Z-1144-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2021%22&limit=1).

The FDA announced on Dec. 18, 2020, that Siemens Medical Solutions USA, Inc. is recalling ARTIS Icono biplane and floor systems with software version VE20B due to misleading error messages and manual gaps. The agency classified the recall as Class II.

How to tell if you have it

  • Siemens ARTIS Icono biplane Model:11327600
  • Siemens ARTIS Icono floor system Model: 11327700
  • Software version VE20B
  • Serial numbers: 180054, 180062, 180019, 180065, 180056, 180057, 180041, 180084, 180034, 180072, 180060, 170026, 180070, 180048, 180083, 180080, 180067, 180040, 180029, 170023, 180068, 170025, 180018, 180047, 180046, 180085, 180035, 180081, 170051, 170027, 180043, 170053, 180049, 180077, 180053, 180055, 180015, 180014, 180066, 180082, 180037

The hazard

GovInfoNow's records show the recall addresses misleading error messages and gaps in the Operator Manual for ARTIS Icono systems with software version VE20B. Potential issues include system error management, erroneous error messages, zoom/pan function errors, grid indication problems, and coolant level inaccuracies. These defects may cause procedures to be terminated and performed on an alternative x-ray system.

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: Loose Screws Risk Falling (June 8, 2026), Siemens ARTIS icono ceiling: Risk of loss of movement after extreme height adjustments (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A: Risk of inaccurate 3D scans due to radiation exposure (March 12, 2026). Other recent recalls of similar products include Philips Allura Xper FD20/20 OR Table Recall: X-ray Imaging May Not Start Properly (March 3, 2026), Philips ALLURA Xper FD20 Biplane X-ray System May Not Start Properly (March 3, 2026), and Philips Allura Xper FD20/10 X-ray System May Not Start Properly (March 3, 2026).

How to tell if you have this one

Check for ARTIS Icono biplane model 11327600 or floor system model 11327700 with software version VE20B. Serial numbers listed in the recall include 180054, 180062, and other numbers from 170023 to 180085.

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

What to do — step by step

  1. Check Software Version

    Verify the software version on your ARTIS Icono system; if it is VE20B, it is affected.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Dec 18, 202012. FDA classified it Class II: Feb 23, 202123. Published in FDA’s Enforcement Report: Mar 3, 202134. FDA terminated the recall: Nov 17, 2021420202021
  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.

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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-1144-2021 (December 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1144-2021 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