The Recall Desk
HighFDA (Devices)·Z-2771-2026·Announced 2026-07-29

Boston Scientific TheraSphere 360 Y-90 Management Platform Software Recall Due to Calculation Error

Boston Scientific Corporation is recalling the TheraSphere 360 Y-90 Management Platform (Model M00139509001) due to a software anomaly that may cause incorrect dose calculations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software error that could lead to incorrect dosage calculations, representing a high-risk scenario where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling the TheraSphere 360 Y-90 Management Platform, Model Number M00139509001 (Radiological Image Processing System). This recall affects 68 units distributed nationwide across several US states.

A software anomaly occurs when a user adds vials to the cart and then returns to the Activity Calculator to modify an input. While the dose calculation updates correctly upon selecting "Recalculate," any vials previously added to the cart do not automatically update to reflect the revised calculation.

This issue affects all released software versions (V1.1.2, V1.2.1, V1.2.2, V2.0.1, and V2.0.2).

The recalled product

Product
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Radiological Image Processing System
Hazard
  • software-error
  • dosage-calculation-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • UDI/DI 00191506068264
  • All released software versions (V1.1.2
  • V1.2.1
  • V1.2.2. V2.0.1
  • V2.0.2)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category