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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 68
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
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