Z-2771-2026 Class II Ongoing
FDA device recall Z-2771-2026 was initiated by Boston Scientific Corporation on June 19, 2026 and is designated Class II. 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 "Recal… The recall status is ongoing. Affected quantity: 68 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 units
Product Description
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.
Distribution Pattern
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.
Code Information
UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)