United StatesBoston Scientific TheraSphere 360 Y-90 Management Platform (Radiological Image Processing System), Model M00139509001, UDI/DI 00191506068264, all released software versions V1.1.2, V1.2.1, V1.2.2, V2.0.1 and V2.0.2, distributed nationwide in the US (68 units) is affected. It was recalled because a software anomaly can cause vials previously added to the cart not to update when a user modifies inputs and selects “Recalculate,” so the vials in the cart may not reflect the revised dose calculation.
What's being recalled
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Recalling firm: Boston Scientific Corporation, Maple Grove, MN, United States.
How to identify it
UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada