TheraSphere 360 Y-90 Management Platform
Boston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.
Contact Boston Scientific for software update instructions. Do not use the system until the update is applied.
Why it was recalled
Boston Scientific is recalling the TheraSphere 360 Y-90 Management Platform, a radiological image processing system, due to a software anomaly. When a user modifies input in the Activity Calculator and recalculates, the dose calculation updates correctly but previously added vials are not automatically updated to reflect the revised calculation, potentially leading to incorrect dose administration.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification