Lower riskMedical device recall · FDA · Published March 9, 2026
Siemens ARTIS Icono X-Ray System May Show 0 Dose During Exams
Siemens recalls ARTIS Icono biplane and ceiling models that may display 0 x-ray dose during patient exams, but actual radiation is still applied. Affected units have specific model numbers and UDI codes.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
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Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer
Siemens is recalling certain ARTIS Icono biplane and ceiling x-ray systems because they occasionally show a 0 x-ray dose reading during exams, even though real radiation is still being delivered to patients. This could lead to unintended radiation exposure during procedures. Read more at govinfonow.com/recall/49766-siemens-artis-icono-x-ray-system-may-show-0-dose.
“Siemens ARTIS Icono X-Ray System May Show 0 Dose During Exams.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49766-siemens-artis-icono-x-ray-system-may-show-0-dose. Based on FDA recall #Z-2206-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2026%22&limit=1).
The FDA announced on March 9, 2026, that Siemens Medical Solutions USA, Inc. is recalling ARTIS Icono biplane, floor, and ceiling interventional fluoroscopic x-ray systems. The devices may sporadically display a zero x-ray dose despite actual radiation being applied to the patient.
How to tell if you have it
ARTIS icono biplane Model 11327600
ARTIS icono ceiling Model 11328100
ARTIS icono floor Model 11327700
The hazard
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
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 Biplane Recall (May 20, 2026), and Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include AGFA DR 800 X-Ray System Recall (Nov. 18, 2025) and RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025).
How to tell if you have this one
Check for the model numbers: ARTIS Icono biplane Model 11327600 or ceiling Model 11328100. Also look for the unique device identifiers (UDIs) listed in the recall notice.
Brand
Siemens
Category
Medical device
FDA recall event · 2 products
All 2 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
Ongoing
Distribution
US and Worldwide
Recall number
Product, codes & lots
Quantity
Z-2205-2026
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system; UDI: 4056869046877
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Z-2206-2026
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system; ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
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Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify if your system is ARTIS Icono biplane Model 11327600 or ceiling Model 11328100.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2206-2026 (March 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2206-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.