BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1316-2015 · Initiated February 16, 2015

    Recall

    Recall Number
    Z-1316-2015
    Event Number
    70657
    Firm
    Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
    FEI Number
    3002619595
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    February 16, 2015
    Posted
    March 25, 2015
    Terminated
    February 28, 2017

    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.

    Action

    BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. Brainlab provided existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian TrueBeam system) with the product notification information. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customer starting August 2015 to schedule the update installation. For further questions please call Customer Hotline + 49 89 99 15 68 44 or 1-800 597-5911 ( For US Customers only)

    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)