It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review, searches, circulation, and training purposes. A similar document is provided for warning letters. You can request...Read More

The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically. This compilation is provided in reverse chronological order and is useful for quick...Read More

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...Read More