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Medium risk Drugs & MedicationsClass II

Siemens Medical Solutions USA, Inc Recall

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Updated March 10, 2026

Siemens Medical Solutions USA, Inc is recalling ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.. Hazard: 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.

Is the Siemens Medical Solutions USA, Inc recalled? Yes. This product was recalled by FDA on March 10, 2026. Details below.

What is recalled

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

FDA Mandated

The hazard

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.

Brands affected

Siemens Medical Solutions USA, Inc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1653-2026
Classification
Class II
Recalled
March 10, 2026
Read the official notice

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