FDA-Device2018-10-03Class II
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Medtronic Navigation, Inc.
Hazard
Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.
Sold states
U.S.: MN, NY, PA, FL, AZ, MA, VA, CA, CO, AL, WI, TX, MO, DC, OH, NH, GA, SC, NJ, WA, CT, MI, OK, IN, MD, IL, KY, LA, OR, RI, UT, AR, MS, TN, NC Foreign: United Kingdom, Germany, Switzerland, Netherlands, Israel
Affected count
161
Manufactured in
826 Coal Creek Cir, Louisville, CO, United States
Products
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3251-2018Don't want to check this manually?
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