BEUDAMED
    FDA Enforcement Class II Terminated

    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..

    Recall: Z-1316-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1316-2015
    Event ID
    70657
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2015
    Initiation Date
    February 16, 2015
    Classification Date
    March 25, 2015
    Termination Date
    February 28, 2017
    Address
    Kapellenstrasse 12, Feldkirchen, N/A, Germany

    Description

    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..

    Reason

    The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.

    Code Info

    ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0. Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; The software may be contained in configured items: 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA; 49973B, ET DATA PREP / REVIEW SYSTEM; 49973A, ET DATA PREP / REVIEW SYSTEM; 49973, ET DATA PREP / REVIEW SYSTEM; 49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT; 48302, ET DATA PREP / REVIEW SYSTEM

    Distribution

    Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.

    Quantity

    24 systems (US); 36 systems (Foreign)