Recall – Ultrasound system does not archive data properly with new software

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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