{"url_path":"/fda/device/recalls/Z-2288-2026","section_key":"summary","section_title":"DEVICE Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 7B12/12, Model Numbers:  722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2023-12-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2288-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V."},"word_count":163,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2288-2026\n\n**Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.\n**Classification:** Class II\n**Status:** Ongoing\n**Initiated:** 2023-12-07\n**Report date:** 2026-06-10\n\n## Product\nPhilips Azurion 7B12/12, Model Numbers:  722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key\n\n## Reason\nDuring the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable.  The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.\n\n## Affected lots\nUDI (01)00884838099265(21)104, (01)00884838085350(21)221, (01)00884838099265(21)153, (01)00884838099265(21)46, (01)00884838099265(21)28, (01)00884838085350(21)250, (01)00884838099265(21)72, (01)00884838099265(21)208, (01)00884838099265(21)41, (01)00884838099265(21)122, (01)00884838099265(21)147, (01)00884838085350(21)225, (01)00884838099265(21)262, (01)00884838099265(21)112, (01)00884838099265(21)110, (01)00884838099265(21)207, (01)00884838099265(21)68, (01)00884838099265(21)177, (01)00884838099265(21)29, (01)00884838099265(21)71, (01)00884838099265(21)37, (01)00884838099265(21)175, (01)00884838099265(21)148, (01)00884838099265(21)205, , (01)00884838099265(21)229, (01)00884838099265(21)228, (01)00884838085350(21)277, (01)00884838085350(21)115, (01)00884838099265(21)157, (01)00884838085350(21)163, (01)00884838099265(21)268, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)208, (01)00884838085350(21)104, (01)00884838085350(21)244, (01)00884838085350(21)234, (01)00884838099265(21)53, (01)00884838099265(21)259, (01)00884838099265(21)55, (01)00884838099265(21)235, (01)00884838099265(21)298, (01)00884838085350(21)70, (01)00884838099265(21)233, (01)00884838099265(21)141, (01)00884838099265(21)289, (01)00884838099265(21)249, (01)00884838099265(21)84, (01)00884838099265(21)111, (01)00884838099265(21)227.\n\n## Distribution\nUS Nationwide distribution."}