Events

Retiro De Equipo (Recall) de Brainlab AG ExacTrac 6.0.x

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Brainlab AG.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71898
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2440-2015
  • Fecha de inicio del evento
    2015-08-05
  • Fecha de publicación del evento
    2015-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139302
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Exactrac 6.0 patient positioning system: display of potentially incorrect digitally reconstructed radiograph (drr) for x-ray correction and verification.
  • Acción
    Brainlab intends to distribute the Field Safety Notice / Product Notification letter CAPA-20150713-001446, dated July 20, 2015, to the customers. The letter provides instructions for the user on how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue. The Field Safety Notice / Product Notification letter states that as generally required, always verify that the correct DRRs for the current patient are displayed in ExacTrac and an accurate fusion to the X-Ray images is possible for patient positioning. In case incorrect DRRs are displayed, exit and re-start the ExacTrac software. To minimize the probability of this issue occurring for the affected ExacTrac versions: -Reduce the amount of contours exported to ExacTrac as far as possible. -Avoid exporting large contours, such as couch top models, to ExacTrac. -After every (re-)start of the ExacTrac application on any workstation, always first load a phantom plan not containing contours. The Field Safety Notice / Product Notification letter states that as a general reminder the user should always follow the instructions and warnings as described in the user guide. In the context of this notification please specifically consider the safety notes relevant for X-ray correction and verification: -The image overlay functions must be used to verify fusion accuracy in both image views, especially if the images contain a series of similar structures such as vertebrae. -Do not perform patient treatment unless accurate image fusion is possible. -Large correction shifts (e.g. greater than 10 mm) may indicate incorrect automatic fusion. In such cases, verify the correction shift a second time. Brainlab Corrective Action: 1. Existing potentially affected ExacTrac 6.0.x customers receive the product notification information. 2. Brainlab will provide a software revision (ExacTrac v. 6.0.6) with this issue solved to affe

Device

Brainlab AG ExacTrac 6.0.x
  • Modelo / Serial
    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
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Dirección del fabricante
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    USFDA