Recall – Cl II VISUALASE THERMAL THERAPY SYSTEM

Company: Medtronic Navigation, Inc.
Date of Enforcement Report 10/3/2018
Class lI:

PRODUCT

Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: 9735542

Recall Number: Z-3251-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc. Louisville, CO on 6/1/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
161

DISTRIBUTION
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

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