{"url_path":"/fda/device/recalls/Z-3014-2026","section_key":"summary","section_title":"DEVICE Recall: Canon Medical System, USA, INC. — Alphenix Models  INFX-8000C  INFX-8000F  INFX-8000V    This device is a digital radiography/fluoroscopy system used in a diagnostic and  interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-08-04","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3014-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Canon Medical System, USA, INC."},"word_count":217,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3014-2026\n\n**Recalling firm:** Canon Medical System, USA, INC.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-04\n**Report date:** 2026-09-02\n\n## Product\nAlphenix Models  INFX-8000C  INFX-8000F  INFX-8000V    This device is a digital radiography/fluoroscopy system used in a diagnostic and  interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.\n\n## Reason\nDue to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.\n\n## Affected lots\nModel Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165   Serial Number: B3E2422005   Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC2412001  Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004    Model Number: INFX-8000V/SX UDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002  Model Number: INFX-8000V/B9 UDI code: Pending SID Number: 30059175 Serial Number: B9F2412001  Model Number: INFX-8000V/ST UDI code: Pending SID Number: 30059180 Serial Number: STA2412001  Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30095017 Serial Number: SZA2432003 SID Number: 30097052 Serial Number: SZA2422002\n\n## Distribution\nU.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX."}