FDA-Device2020-05-06Class II
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Boston Scientific Corporation
Hazard
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.
Sold states
OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
Affected count
150 units
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1804-2020Don't want to check this manually?
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