Company: Brainlab AG
Date of Enforcement Report 6/15/2016
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Recall Number Z-1729-2016
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Brainlab AG, Feldkirchen, Germany on 5/4/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.