Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological
Pending LLM rewrite. Source: FDA_DEVICE Z-2771-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
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 — Devices
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.
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