{"recall":{"id":"fda-device-99236","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform","firm":"Boston Scientific Corporation","date":"2026-06-19","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.","code":"UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)","quantity":"68 units","number":"Z-2771-2026","classification":"Class II"}],"reason":"Software 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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US 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.","nationwide":true,"states":[],"units":"68 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99236","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"09fb601691055be2","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99236","record":[{"status":"Ongoing","city":"Maple Grove","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99236","recalling_firm":"Boston Scientific Corporation","address_1":"1 Scimed Pl","address_2":"N/A","postal_code":"55311-1565","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"US 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.","recall_number":"Z-2771-2026","product_description":"Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.","product_quantity":"68 units","reason_for_recall":"Software 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.","recall_initiation_date":"20260619","center_classification_date":"20260722","report_date":"20260729","code_info":"UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)"}]}}