Boston Scientific TheraSphere 360 Y-90 software anomaly may cause incorrect dose calculations
What this means
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.
- 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
- Verify that vials in the cart match the most recent calculation before use
- Report any calculations or dosing errors to Boston Scientific immediately
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2771-2026More Boston Scientific recalls
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