BEUDAMED
    FDA Enforcement Class II Terminated

    ExacTrac Vero is a Patient Positioning System for Radiation therapy.

    Recall: Z-1929-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1929-2016
    Event ID
    74265
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    May 4, 2016
    Classification Date
    June 8, 2016
    Termination Date
    July 24, 2017
    Address
    Kapellenstr. 12, N/A, Feldkirchen, N/A, N/A, Germany

    Description

    ExacTrac Vero is a Patient Positioning System for Radiation therapy.

    Reason

    Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

    Code Info

    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

    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.

    Quantity

    27 Systems