FDAFDA · Food and drugs·Recall number Z-2771-2026
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Published July 29, 2026 · Recall initiated: June 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- 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.
- Lot
- UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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