Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Boston Scientific Corporation
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI/DI 00191506068264Model All released software versions (V1.1.2Model V1.2.1Model V1.2.2. V2.0.1Model V2.0.2)UPC 00191506068264Would you have heard about this one?
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