Recalling firm: Boston Scientific Corporation
Device class: 2
Device name: System, Image Processing, Radiological
Event initiated: 2026-06-19
FDA posted: 2026-07-22
Recall ID: Z-2771-2026
Product: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
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.