Boston Scientific Corporation: System, Image Processing, Radiological
Boston Scientific TheraSphere 360 Y-90 Management Platform Recall Boston Scientific is recalling its TheraSphere 360 Y-90 Management Platform, a radiological image processing system used for dose calculations in medical procedures. The software has a defect where if a user modifies calculation inputs and recalculates, the previously added vials in the cart don't automatically update to match the new calculation results. This Class II recall affects hospitals and medical facilities nationwide that use this device.
- Recalling firm
- Boston Scientific Corporation
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1518baa8-0cd7-4c18-abc8-dd5e6f1b2493