Events

Retiro De Equipo (Recall) de Device Recall BRAINLAB EXACTRAC VERO

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
    78488
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0172-2018
  • Fecha de inicio del evento
    2017-11-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159653
  • 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
    Brainlab has internally detected that under specific conditions exactrac vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. this may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. this deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
  • Acción
    The firm notified their consignees by email on November 3, 2017. "Instructions to customers what to do with the recalled product. For instructions for the user how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue, please also refer to the User Corrective Action section in the attached Field Safety Notice / Product Notification letter CAPA-20171011-001985: 1. After applying a couch shift always perform a verification image of the patient position before enabling the treatment beam. 2. Do not use the Virtual Isocenter function if a verification of the patient position in the treatment isocenter is not feasible. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Clinical User Guide ExacTrac Vero: Brainlab highly recommends performing an X-ray verification after each change to the couch/Robotics Position." For further questions, please call 1 (800) 784-7700.

Device

Device Recall BRAINLAB EXACTRAC VERO
  • Modelo / 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
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
  • Descripción del producto
    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

Manufacturer

Brainlab AG
  • Dirección del fabricante
    Brainlab AG, Olof-Palme-Strasse 9, Munich Germany
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    USFDA