FDA DeviceClass IINotable

FDA Recall: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological

Date: 2026-07-29
Brand: Boston Scientific Corporation
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

68 units

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