Lower riskMedical device recall · FDA · Published March 10, 2026
Siemens ARTIS pheno and Icono Biplane X-Ray Recalls: Sporadic Dose Increase Risk
Siemens recalls ARTIS pheno and Icono biplane x-ray systems for potential sporadic dose increases during patient exams. Actual doses remain within regulatory limits but may cause unnecessary radiation exposure.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Take action
Contact the company
📍Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418
✎ GovInfoNow plain-language explainer
Siemens is recalling certain ARTIS pheno and Icono biplane x-ray systems due to sporadic increases in reported x-ray dose during patient exams. While actual doses stay within regulatory limits, this could lead to unnecessary radiation exposure for patients. Read more at govinfonow.com/recall/49761-siemens-artis-pheno-and-icono-biplane-x-ray-recalls-sporadic.
“Siemens ARTIS pheno and Icono Biplane X-Ray Recalls: Sporadic Dose Increase Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49761-siemens-artis-pheno-and-icono-biplane-x-ray-recalls-sporadic. Based on FDA recall #Z-1653-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1653-2026%22&limit=1).
The FDA announced on March 10, 2026, that Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno and ARTIS Icono biplane systems due to a hazard where the device may sporadically display a major increase in x-ray dose applied to the patient. The agency issued recall number Z-1653-2026 for the Class II voluntary recall.
How to tell if you have it
Brand: Siemens
Product: ARTIS pheno and ARTIS Icono biplane, floor and ceiling
Model Numbers: 10849000, 11327600, 11328100, 11327700
ARTIS pheno UDI: 4056869046877
ARTIS icono biplane UDI: 4056869063317
ARTIS icono ceiling UDI: 4056869295923
ARTIS icono floor UDI: 4056869149325
The hazard
According to the FDA, during patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. The agency noted that despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as applicable regulatory requirements.
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 AGFA DR 800 X-Ray System Recall (Nov. 18, 2025), RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025), and GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026).
How to tell if you have this one
Check for model numbers 10849000, 11327600, 11328100, or 11327700 on the device. The unique device identifiers (UDIs) are also listed in the recall notice.
Brand
Siemens
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number on your Siemens ARTIS pheno or Icono biplane x-ray system to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days 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-1653-2026 (March 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1653-2026 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.