iLab Polaris Multi-Modality Guidance System — Class II medical device recall Z-1804-2020
Completed recall by Boston Scientific Corporation, reported 2020-05-06. Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) con
| Recall number | Z-1804-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2019-09-18 |
| Classified | 2020-04-27 |
| Reported by FDA | 2020-05-06 |
| Countries outside the US | BE, DK, ES, FR, GB, JP |
| Quantity | 150 units |
| Reason classes | software |
| Lot numbers | 629774 |
| Serial numbers | 10044, 10053, 10108, 10221, 10261, 10275, 10278, 10312, 10362, 10365, 10443, 10496, 10500, 10501, 10504, 10548, 10565, 10566, 10604, 10651, 10657, 10667, 10694, 10753, 10770 and 118 more |
Product
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Reason for recall
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.
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-1804-2020. 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.