BEUDAMED
    FDA Enforcement Class II Terminated

    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.

    Recall: Z-2440-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2440-2015
    Event ID
    71898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    August 5, 2015
    Classification Date
    August 21, 2015
    Termination Date
    January 5, 2017
    Address
    Kapellenstrasse 12, N/A, Feldkirchen, N/A, N/A, Germany

    Description

    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.

    Reason

    ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.

    Code Info

    Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5). Serial numbers/lot numbers are not applicable for a software version. Software revisions of the ExacTrac software have a specific software version number. Model/catalogue numbers: 70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R 49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4 49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4 49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5 49973 ET DATA PREP / REVIEW SYSTEM 49973A ET DATA PREP / REVIEW SYSTEM 49973B ET DATA PREP / REVIEW SYSTEM 49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

    Distribution

    Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

    Quantity

    361 systems