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Siemens Medical Solutions USA, Inc recalls ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Recalled June 10, 2026 · FDA recall Z-2205-2026 · Siemens Medical Solutions USA
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. · FDA Class II
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Description
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.
Product
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →