Company: Boston Scientific Corporation
Date of Enforcement Report: 5/7/2020
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Recall Number: Z-1804-2020
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.
Boston Scientific Corporation on 9/18/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE