Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior. |
| Product | iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System |
| Quantity | 150 units |
| Distribution | OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees. |
| Initiated | 2019-09-18 |
| Classified | 2020-04-27 |
| Recall number | Z-1804-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1804-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85271/
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