Recall Z-2771-2026
- Recall number
- Z-2771-2026
- Event number
- 99236
- Firm
- Boston Scientific Corporation
- Firm FEI
- 3002095335
- Product code
- LLZ
- Status
- Open, Classified
- Initiated
- 2026-06-19
- Posted
- 2026-07-22
- Root cause
- Device Design
- 510(k) numbers
- K252547, K260479, K073169, K050619, K103565, K042212, K070683, K053183, K131873, K161625, K022970, K151941, K202256, K201202, K163013, K173101, K093982, K000016, K210187, K112354, K992654, K120525, K161109, K212421, K960043, K032096, K081556, K202292, K042647, K242647
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.