{"url_path":"/fda/device/recalls/Z-2284-2026","section_key":"summary","section_title":"DEVICE Recall: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 3M12, Model Numbers: 722063, 722221 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-2284-2026%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":127,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2284-2026\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 3M12, Model Numbers: 722063, 722221 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)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838085275(21)131, (01)00884838099203(21)54, (01)00884838085275(21)84, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838085275(21)132, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)108, (01)00884838085275(21)108.\n\n## Distribution\nUS Nationwide distribution."}