Recall Weekly
Moderate riskFDA DeviceClass II

Boston Scientific TheraSphere 360 Y-90 software anomaly may cause incorrect dose calculations

The TheraSphere 360 Y-90 Management Platform has a software bug that can cause incorrect dose calculations. When a user modifies calculation inputs and recalculates, the new dose is computed correctly on screen, but vials previously added to the cart do not automatically update to match the revised calculation.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. Contact Boston Scientific for guidance on affected software versions V1.1.2, V1.2.1, V1.2.2, V2.0.1, and V2.0.2
  2. Verify that vials in the cart match the most recent calculation before use
  3. Report any calculations or dosing errors to Boston Scientific immediately
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
68 units
Illnesses reported
None reported
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Classification
Class II
Recall number
Z-2771-2026

In the FDA's words

Description
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. 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. UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2) 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. Affected quantity: 68 units
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.

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