Recall Z-3251-2018 ยท LLZ System, Image Processing, Radiological
Medtronic Navigation, Inc.
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
| Date | Jun 1, 2018 |
| Status | Terminated |
| 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. |
| Root 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081656 | VISUALASE THERMAL THERAPY SYSTEM Biotex, Inc., Sep 10, 2008 |