Boston Scientific Corporation: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Read the official notice at FDA (device) →
Get alerts for Boston Scientific
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Boston Scientific Corporation
- Product
- Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-06-19
- Code info
- UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
- Product quantity
- 68 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Maple Grove
- State
- MN
- Country
- United States
- Event id
- 99236
Free daily digest + "My products" watchlist