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TheraSphere 360 Y-90 Management Platform
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MEDICAL DEVICE RECALLMODERATE

TheraSphere 360 Y-90 Management Platform

Boston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.

What to do

Contact Boston Scientific for software update instructions. Do not use the system until the update is applied.

Recalled
Listed
Updated
Recall No.
Z-2771-2026
Agency
FDA
Firm
Boston Scientific Corporation
Recall ID
99236
Status
ONGOING

Recall at a glance

Quantity recalled
68 units

Why it was recalled

Boston Scientific is recalling the TheraSphere 360 Y-90 Management Platform, a radiological image processing system, due to a software anomaly. When a user modifies input in the Activity Calculator and recalculates, the dose calculation updates correctly but previously added vials are not automatically updated to reflect the revised calculation, potentially leading to incorrect dose administration.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.

UDI-DI
00191506068264

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification