{"url_path":"/fda/device/recalls/Z-2771-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2771-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Boston Scientific Corporation"},"word_count":153,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2771-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-19\n**Report date:** 2026-07-29\n\n## Product\nBoston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.\n\n## Reason\nSoftware anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects \"Recalculate\",  the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.\n\n## Affected lots\nUDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)\n\n## Distribution\nUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, LA, MA, MN, NE, NY, OH, OK, OR, SC, SD, TN, TX, UT, WA, WI, WV, WY."}