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Use caution Medical device recall · FDA · Published March 19, 2021

Siemens Interventional Fluoroscopy Systems: Software Issue May Require Alternative X-Ray

Siemens recalls certain Interventional Fluoroscopic X-Ray Systems due to a software issue that may require terminating procedures and switching to an alternative x-ray system.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1497-2021Medical deviceSiemens ›
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Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer

Siemens is recalling specific models of interventional fluoroscopy x-ray systems because of a software issue that could require stopping procedures and using a different x-ray system. This affects medical facilities using these systems for procedures on patients. Read more at govinfonow.com/recall/63021-siemens-interventional-fluoroscopy-systems-software-issue-may-require-alternative-x.

Source Summary by GovInfoNow · govinfonow.com/recall/63021-siemens-interventional-fluoroscopy-systems-software-issue-may-require-alternative-x · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1497-2021

Cite this page

“Siemens Interventional Fluoroscopy Systems: Software Issue May Require Alternative X-Ray.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63021-siemens-interventional-fluoroscopy-systems-software-issue-may-require-alternative-x. Based on FDA recall #Z-1497-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1497-2021%22&limit=1).

The FDA announced on March 19, 2021, that Siemens Medical Solutions USA, Inc. is recalling Interventional Fluoroscopic X-Ray Systems due to a potential software issue that may require terminating planned procedures. The agency issued recall number Z-1497-2021 for the affected devices.

How to tell if you have it

  • Brand: Siemens
  • Product: ARTIS icono biplane (serial numbers starting with 11327600)
  • Product: ARTIS icono floor (serial numbers starting with 11327700)
  • Product: ARTIS pheno (serial numbers starting with 10849000)
  • Software version: VE20C
  • Serial numbers: 180062, 170319, 180317, 180072, 180060, 180048, 180083, 180315, 170305, 180080, 180301, 180305, 180330, 170307, 180040, 180333, 170309, 170310, 170304, 180316, 180334, 170025, 180047, 180085, 180331, 180321, 180309, 170312, 180323, 164703, 170303, 180329, 180015, 180014, 180037
  • Quantity: 133 systems

The hazard

Siemens has become aware of a potential issue with software version VE20C. According to the FDA, planned procedures may have to be terminated and performed on an alternative x-ray system.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has had 182 other recalls since June 6, 2017. Other recent recalls of similar products include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS icono ceiling recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Canon Alphenix INFX-8000F X-Ray System Recall (Dec. 19, 2025) and the Philips Allura Xper FD20/15 OR Table Recall (March 3, 2026).

How to tell if you have this one

Check for the model numbers: ARTIS icono biplane (11327600), ARTIS icono floor (11327700), or ARTIS pheno (10849000). The software version VE20C with specific serial numbers listed in the recall notice may be affected.

  • 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 system; if it is VE20C with the listed serial numbers, it is affected.

  2. Contact Siemens for Guidance

    Reach out to Siemens directly for instructions on whether you need to switch to an alternative x-ray system.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 18 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Delaware, Florida, Illinois, Indiana, Kentucky, Maryland, Michigan, Nebraska, New Jersey, New York, North Carolina, Ohio, Tennessee, Texas, Utah, Wisconsin.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Mar 19, 202112. FDA classified it Class II: Apr 26, 202123. Published in FDA’s Enforcement Report: May 5, 202134. FDA terminated the recall: Nov 9, 202142021
  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-1497-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1497-2021 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