Reported Oct 3, 2018 · Terminated
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- Visualase Thermal Therapy System
- Software
Visualase Software versions 3.1.1 - 3.2Product #: 9735542
- Lot codes and dates
- UDI #: 00643169655935, 00643169792890, 00643169905719, Serial #:071217-001
158 of 158 codes
110317-001110603.001110720.01110825.01111103.01120601-001120711.01120920.01130507.01130523.01130703.011320781320841321601321891321901322301420711422861423101423511423521427691428151428581501751513081513291513941514601515971516972UA9160WND50610.00180414.00181215.00190112.00190515.0190519.02CCS40011N06183105N06187582N06201398N06201536N06203635N06205585N06207497N06208756N06210356N06211047N06211282N06218634N06228349N06233025N06237425N06241803N06241804N06241913N06242904N06245890
- UDI #: 00643169655935, 00643169792890, 00643169905719, Serial #:071217-001
- Amount recalled
- 161
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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