Class 2 Device Recall Visualase Thermal Therapy System

• Date Initiated by Firm: June 01, 2018
• Create Date: September 26, 2018
• Recall Status: Terminated on February 02, 2022
• Recall Number: Z-3251-2018
• Recall Event ID: 80308
• 510(K)Number: K081656
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
• Code Information: UDI #: 00643169655935, 00643169792890, 00643169905719, Serial #:071217-001 110317-001 110603.001 110720.01 110825.01 111103.01 120601-001 120711.01 120920.01 130507.01 130523.01 130703.01 132078 132084 132160 132189 132190 132230 142071 142286 142310 142351 142352 142769 142815 142858 150175 151308 151329 151394 151460 151597 151697 2UA9160WND 50610.001 80414.001 81215.001 90112.001 90515.01 90519.02 CCS40011 N06183105 N06187582 N06201398 N06201536 N06203635 N06205585 N06207497 N06208756 N06210356 N06211047 N06211282 N06218634 N06228349 N06233025 N06237425 N06241803 N06241804 N06241913 N06242904 N06245890 N06251476 N06253719 N06253740 N06259079 N06262594 N06263649 N06265357 N06267972 N06267973 N06267974 N06269032 N06269438 N06269439 N06270019 N06278606 N06278607 N06278608 N06278609 N06279636 N06289894 N06289895 N06289896 N06289897 N06303708 N06303710 N06303711 N06319401 N06319402 N06319403 N06319404 N06320401 N06320795 N06502349 N06502350 N06503495 N06503496 N06671901 N06671902 N06676031 N06676032 N06676033 N06685201 N06685202 N06685203 N06685204 N06685206 N06687250 N06687251 N06687252 N06687253 N06687254 N06688835 N06734368 N06734369 N06740305 N06757275 N06763190 N06764462 N06767959 N06768840 N06772396 N06774642 N06774643 N06774644 N06777604 N06781010 N06805982 N06805983 N06807016 N06807017 N06807018 N06807019 N07279689 N07279690 N07279692 N07279693 N07291034 N07291035 N07291036 N07291037 N07291038 N07300434 N07372598 N07385291 N07385292 N07389258 N07389259 N07389260 N07582374 N07582375 N07816044 N07816045 N07816046 N07400747 N07400744 100811-001 N07400746 N07400745
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 826 Coal Creek Cir; Louisville CO 80027-9710
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 06/01/2018, Urgent Medical Device Correction letters and Consignee Response Forms were mailed to customers via overnight mail service. Customers were provided with additional information intended to supplement the system manual and instructed to call the firm at 1-888-826-5603 if they had any questions.
• Quantity 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ and Original Applicant = BIOTEX, INC.