Recalling firm
Siemens Medical Solutions USA, Inc
Product type
Device
Status
Ongoing
Report date
2026-06-10
Distribution
US and Worldwide
Firm state
PA
Initiated by
FDA Mandated
Reason for recall
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 description
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Code / lot info
UDI: 4056869046877
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.