Device Recall Brainlab ExacTrac 6.x Patient Positioning System

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Société-mère du fabricant (2017)
  • Source
    USFDA