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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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