Recall Z-3251-2018— Medtronic Navigation, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2018-06-01, terminated 2022-02-02. It names one FDA 510(k) clearance: K081656. Product: Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542. 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
- Medtronic Navigation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-01
- Terminated
- 2022-02-02
- Firm location
- Louisville, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.