Boston Scientific recalls TheraSphere 360 Y-90 Management Platform software versions with a calculation error when modifying inputs after adding vials to cart. Affected units may need correction.
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.
Boston Scientific is recalling a specific software version of their TheraSphere 360 Y-90 Management Platform due to an error in dose calculations when users modify inputs after adding vials to the cart. This could lead to incorrect radiation dosing during medical procedures.
The software has a bug where adding vials to the cart and then changing inputs causes previously added vials to not update correctly when recalculating doses. This could lead to incorrect radiation dosing for patients during medical procedures.
Medical professionals using the TheraSphere 360 Y-90 Management Platform software versions V1.1.2 through V2.0.2 are most at risk. Patients receiving radiation therapy may be affected if the software error impacts dose calculations.
Check if you have the TheraSphere 360 Y-90 Management Platform with model number M00139509001 and software versions V1.1.2, V1.2.1, V1.2.2, V2.0.1, or V2.0.2. The product was sold with UDI/DI 00191506068264.
Verify your software version by checking the product's documentation or settings menu.
The recall addresses a software error that could lead to incorrect radiation dosing, but it does not pose an immediate risk of serious injury.
Check if your software version is V1.1.2, V1.2.1, V1.2.2, V2.0.1, or V2.0.2 with model number M00139509001.
The recall does not specify a remedy, so you should check with Boston Scientific for guidance on potential corrections.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2771-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2771-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
