Boston Scientific TheraSphere 360 Y-90 Management Platform — Class II medical device recall Z-2771-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-07-29, distributed nationwide. Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activit
| Recall number | Z-2771-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2026-06-19 |
| Classified | 2026-07-22 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 68 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00191506068264 |
| Model numbers | M00139509001 |
Product
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2771-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.