Recall Z-2771-2026— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-06-19. It names 2 FDA 510(k) clearances: K260479, K252547. Product: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.. 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-19
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K260479 — TheraSphere 360 Y-90 Management Platform
- K252547 — TheraSphere 360 Y-90 Management Platform
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.