Recall Z-2771-2026 · LLZ System, Image Processing, Radiological
Boston Scientific Corporation
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
| Date | Jul 22, 2026 (initiated Jun 19, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Boston Scientific initially notified their consignees via teleconference on 6/19/2026 and followed with a notice distributed on the same date via email. The notice explained the issue, potential harms, and requested the following: "Required User Actions " Follow the instructions provided in the TheraSphere 360 Ordering Quick Guide. " Remove and reselect vials if inputs into the Activity calculator (Lung Shunt Fraction, Anticipated Residual Waste, and/or Target Volume) are changed after any vials were added to the cart. " Verify that the vial information displayed in the cart and treatment d |
| Quantity | 68 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |