FDA recall, , Moderate risk
Siemens Artis Pheno and Artis Icono Interventional Fluoroscopic X-Ray Systems
These interventional fluoroscopic x-ray systems may show a 0 dose while actually applying x-ray to the patient.
Summary by Recall Canary from the FDA notice
What happened
Siemens Medical Solutions USA, Inc., of Malvern, Pennsylvania, recalled its Artis Icono biplane and Artis pheno interventional fluoroscopic x-ray systems because during patient examinations the systems may sporadically display a 0 x-ray dose administered to the patient, while an actual x-ray dose is applied. The behavior has only been observed during fluoroscopy and/or single-frame acquisitions.
The company began the recall on March 9, 2026, and the FDA classified it on June 4, 2026, with distribution in the US and worldwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 4056869063317
- 4056869295923
- 4056869149325
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- UDI-DI
- 4056869046877
Recall details
- Company began the recall
- Sold in
US and Worldwide
- Company
- Siemens Medical Solutions USA, IncMalvern, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98992
- Recall numbers
- Z-2205-2026 to Z-2206-2026
All recalls from Siemens Medical Solutions USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
