FDA recall Z-1804-2020

Boston Scientific Corporation · Class II · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status: Completed
Initiation date: 2019-09-18
Report date: 2020-05-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1804-2020