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