Boston Scientific Corporation recalls iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

Recall date

September 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1804-2020

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System