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