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Use caution Medical device recall · FDA · Published October 12, 2021

Siemens Artis pheno Software VE20C Recall: Potential Image Corruption and System Shutdowns

Siemens recalls Artis pheno diagnostic imaging angiography systems with software VE20C (model 10849000) due to four software issues that may cause image corruption, system shutdowns, or inability to perform X-rays during procedures.

🇺🇸 FDA recall #Z-0515-2022Medical deviceSiemens ›
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Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer

Siemens is recalling Artis pheno diagnostic imaging systems with software VE20C (model 10849000) because four software issues could lead to corrupted images, system shutdowns, or inability to take X-rays during procedures. This affects medical facilities using these systems for angiography imaging. Read more at govinfonow.com/recall/61693-siemens-artis-pheno-software-ve20c-recall-potential-image-corruption-and.

Source Summary by GovInfoNow · govinfonow.com/recall/61693-siemens-artis-pheno-software-ve20c-recall-potential-image-corruption-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0515-2022

Cite this page

“Siemens Artis pheno Software VE20C Recall: Potential Image Corruption and System Shutdowns.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61693-siemens-artis-pheno-software-ve20c-recall-potential-image-corruption-and. Based on FDA recall #Z-0515-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0515-2022%22&limit=1).

The FDA announced on Oct. 12, 2021, that Siemens Medical Solutions USA, Inc. voluntarily recalled Artis pheno diagnostic imaging angiography systems with software VE20C due to potential software issues. The agency issued recall number Z-0515-2022 for the Class II device.

How to tell if you have it

  • Brand: Siemens
  • Product: Artis pheno with software VE20C diagnostic imaging angiography system
  • Model: 10849000
  • Serial Numbers: 164719, 164712, 164722, 164723, 164728, 164711, 164718, 164703, 164721, 164726, 164724, 164725
  • UDI: 04056869046877
  • Units affected: 12
  • Distribution: US Nationwide

The hazard

According to the FDA, four potential software issues exist with the Artis pheno and Artis icono systems using software VE20C. These include updated calibration data not saving with measurement after scene+/-, inability to take x-rays requiring system shutdown or restart during intervention, corrupted images during Roadmap, and unintended shutdown of the imaging system when using the UPS option.

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 Philips Azurion Systems R3.0 Software Issues (Dec. 8, 2025), Philips Azurion System Software R3.1 May Cause Imaging Loss (Dec. 12, 2025), and Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall (June 17, 2026).

How to tell if you have this one

Check if your Artis pheno system has software VE20C and model number 10849000. The recall includes specific serial numbers (164711-164728) and UDI code 04056869046877.

  • Brand
    Siemens
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0515-2022Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000; Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 0405686904687712 units
Z-0516-2022Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600; Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 18005672 units
Z-0517-2022Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700; Serial Numbers: 170319 170026 170343 170305 170307 170331 170309 170310 170023 170304 170328 170334 170336 170025 170346 170051 170333 170332 170312 170027 170303 170322 170053 UDI: 0405686914932523 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your Artis pheno system has software VE20C and model number 10849000.

  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 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 2.5 years after the firm started it.

1. Firm started the recall: Oct 12, 202112. FDA classified it Class II: Jan 21, 202223. Published in FDA’s Enforcement Report: Feb 2, 202234. FDA terminated the recall: Apr 11, 2024420212024
  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-0515-2022 (October 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0515-2022 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