Devices

Device Recall Brainlab ExacTrac

  • Model / Serial
    ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE;  2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE;  3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE;  4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE;  5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR);  6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR);  7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR);  8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED;  9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC;  10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4;  11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4;  12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R;  13) 49973B ET DATA PREP / REVIEW SYSTEM;  14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY;  15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED;  16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
  • Product Description
    ExacTrac is 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, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
  • Manufacturer
    Brainlab AG
  • 1 Event

Manufacturer

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

2 devices with a similar name

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Device Recall Brainlab ExacTrac 6.x Patient Positioning System
  • Model / Serial
    Software Versions: ExacTrac v. 6.x (v. 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;  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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
  • Product Description
    ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
  • Manufacturer
    Brainlab AG
Device Recall BRAINLAB EXACTRAC VERO
  • Model / Serial
    Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field). UDI: 04056481132446
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
  • Product Description
    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: || 46228 EXACTRAC VERO 3.5 || 46238 EXACTRAC VERO 3.5 || 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 || 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 || The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
  • Manufacturer
    Brainlab AG