{"url_path":"/fda/device/recalls/Z-2205-2026","section_key":"summary","section_title":"DEVICE Recall: Siemens Medical Solutions USA, Inc — ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-09","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2205-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Siemens Medical Solutions USA, Inc"},"word_count":90,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2205-2026\n\n**Recalling firm:** Siemens Medical Solutions USA, Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** FDA Mandated\n**Initiated:** 2026-03-09\n**Report date:** 2026-06-10\n\n## Product\nARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system\n\n## Reason\nDuring 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.\n\n## Affected lots\nUDI: 4056869046877\n\n## Distribution\nUS and Worldwide"}