Use cautionMedical device recall · FDA · Published September 18, 2020
Siemens ARTIS Icono X-Ray System Recall: Software Issue May Cause Incorrect Catheter
Siemens recalls ARTIS Icono Interventional Fluoroscopic X-Ray systems with software version VE20B due to a rare risk of incorrect catheter visualization during procedures, potentially endangering patients.
There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.
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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 ARTIS Icono and ARTIS Pheno X-ray systems with software version VE20B. In rare cases, moving the C-Arm or table during a procedure could cause the system to display an inaccurate catheter position relative to blood vessels, which might lead to patient injury. Read more at govinfonow.com/recall/64260-siemens-artis-icono-x-ray-system-recall-software-issue-may.
“Siemens ARTIS Icono X-Ray System Recall: Software Issue May Cause Incorrect Catheter.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64260-siemens-artis-icono-x-ray-system-recall-software-issue-may. Based on FDA recall #Z-0400-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2021%22&limit=1).
The FDA announced on Sept. 18, 2020, that Siemens Medical Solutions USA, Inc. is recalling ARTIS Icono and ARTIS Pheno interventional fluoroscopic X-ray systems due to a software hazard. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Siemens
Product: ARTIS Icono Interventional Fluoroscopic X-Ray system, model # 11327600 (Icono biplane) and model # 11327700 (Icono Floor)
According to the FDA, a software problem affects the DSA Roadmap application on systems with software version VE20B. In rare cases, if the DSA acquisition starts while the C-Arm or table is moving, there may be a shift between images, leading to an inaccurate DSA vessel map overlay. This could imply danger to the patient by causing users to rely on incorrect visualization of the catheter relative to the vessel map.
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 floor recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026), GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), and Philips Azurion System Software R3.1 recall (Dec. 12, 2025).
How to tell if you have this one
Check for the ARTIS Icono biplane model #11327600 or ARTIS Icono Floor model #11327700. Serial numbers listed in the recall include 170023 through 180072 (excluding 180071).
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your system; affected units have version VE20B.
Contact Siemens for Updates
Reach out to Siemens directly for guidance on whether your system needs correction.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0400-2021 (September 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0400-2021 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.