Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1804-2020 — iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

U.S. FDA — Device Enforcement · United States · 2019-09-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1804-2020
Date of alert
2019-09-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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