FDA-Device2014-04-30Class II
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Boston Scientific Corporation
Hazard
Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.
Sold states
USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
Affected count
9 units
Manufactured in
47215 Lakeview Blvd, N/A, Fremont, CA, United States
Products
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1487-2014Don't want to check this manually?
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