Device Recall Brainlab AG ExacTrac Vero

  • Model / Serial
    Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version.  Model/catalogue numbers:   20892 EXACTRAC VERO SOFTWARE 3.5 20892A EXACTRAC VERO SOFTWARE 3.5.1 20892B EXACTRAC VERO SOFTWARE 3.5.2 20892C EXACTRAC VERO SOFTWARE 3.5.3 20893 VERO INFRARED POSITIONING/MONITORING SW 46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1 46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC 46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46228 EXACTRAC VERO 3.5 ROW 46238 EXACTRAC VERO 3.5 JAPAN
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    ExacTrac Vero is a Patient Positioning System for Radiation therapy.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Brainlab AG, Kapellenstr. 12, Feldkirchen Germany
  • Manufacturer Parent Company (2017)
  • Source
    USFDA