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