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Use caution Medical device recall · FDA · Published June 30, 2021

Siemens Artis Models with SW VD12 Software Error May Delay Treatment

Siemens recalls Artis zee floor, ceiling, and MP models with software version VD12 due to potential startup failures that could delay clinical treatment. Affected units have specific serial numbers listed in the recall notice.

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

🇺🇸 FDA recall #Z-2404-2021Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355
✎ GovInfoNow plain-language explainer

Siemens is recalling Artis zee floor, ceiling, and MP models with software version VD12 because a software error may cause the imaging system to fail during startup or restart, potentially delaying critical clinical treatments. This recall affects specific serial numbers listed in the notice. Read more at govinfonow.com/recall/62258-siemens-artis-models-with-sw-vd12-software-error-may-delay.

Source Summary by GovInfoNow · govinfonow.com/recall/62258-siemens-artis-models-with-sw-vd12-software-error-may-delay · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2404-2021

Cite this page

“Siemens Artis Models with SW VD12 Software Error May Delay Treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62258-siemens-artis-models-with-sw-vd12-software-error-may-delay. Based on FDA recall #Z-2404-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2404-2021%22&limit=1).

The FDA announced on June 30, 2021, that Siemens Medical Solutions USA, Inc. is recalling Artis angiography systems with software version VD12 due to a software error that may delay clinical treatment. The agency classified the recall as Class II.

How to tell if you have it

  • Siemens Artis zee floor (Serial Number 10094135)
  • Siemens Artis zee ceiling (Serial Number 10094137)
  • Siemens Artis zee MP (Serial Number 10094139)
  • Siemens Artis Q floor (Serial Number 10848280)
  • Siemens Artis Q ceiling (Serial Number 10848281)
  • Siemens Artis Q biplane (Serial Number 10848282)
  • Siemens Artis Q.zen floor (Serial Number 10848353)
  • Siemens Artis Q.zen ceiling (Serial Number 10848354)
  • Siemens Artis Q.zen biplane (Serial Number 10848355)
  • Units with SW version VD12 and Serial Numbers: 104005, 104007, 104012, 104013, 105500, 105501, 109645, 110001, 110005, 110006, 110007, 110014, 110016, 110017, 110018, 110022, 110023, 110024, 110025, 110026, 110027, 110031, 110032, 110035, 110036, 110037, 110039, 110040, 110041, 110042, 110043, 110044, 110046, 110048, 110051, 111133, 111500, 111501, 111502, 111503, 111504, 111505, 111506, 111507, 111508, 111510, 122001, 122002, 122005, 122007, 123501, 123502, 139012, 150002, 150003, 150005, 150009, 150011, 159010, 159015, 159021, 159024, 159025, 159026, 159028, 159030, 159032, 159034, 159037, 159038

The hazard

According to the FDA, a software error in the Image Acquisition System (IAS) may sporadically fail during startup or restart. This failure can result in a delay of clinical treatment.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Recent similar recalls include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS Icono Biplane Recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Philips Achieva 3.0T MRI Recall (August 21, 2026) and the Philips Azurion Systems R3.0 Software Issues recall (December 8, 2025).

How to tell if you have this one

Check if your Siemens Artis model has software version VD12. Affected units include Artis zee floor (serial 10094135), Artis zee ceiling (serial 10094137), Artis zee MP (serial 10094139), and other models with specific serial numbers listed in the recall notice.

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

What to do — step by step

  1. Check Software Version

    Verify your Artis model's software version; affected units have version VD12.

  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; the notice names 30 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Jun 30, 202112. FDA classified it Class II: Sep 2, 202123. Published in FDA’s Enforcement Report: Sep 8, 202134. FDA terminated the recall: Feb 10, 2023420212023
  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

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the device immediately?

No. The recall requires checking the software version and contacting Siemens for guidance, as the hazard does not cause immediate danger but may delay treatment.

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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-2404-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2404-2021 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