Events

Retiro De Equipo (Recall) de Device Recall BrainLAB Target Positioner for Leksell Headring

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
    38170
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1010-2007
  • Fecha de inicio del evento
    2007-06-05
  • Fecha de publicación del evento
    2007-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53091
  • 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
    Radiation therapy treatment Target Positioner - Product Code IWY
  • Causa
    Target alignment error : a mechanical component/software incompatibility caused by a specific combination of the brainlab target positioner version 40700-3a for leksell headrings and brainlab planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.
  • Acción
    BrainLAB immediately notified all customers with the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring, via e-mail on June 5, 2007. The Urgent Medical Device Product Notification letter dated June 4, 2007 included in the e-mail informed the customers that both the BrainSCAN and iPlan RT Dose treatment planning software calculates the isocenter position printed on the Target Positioner Overlays shifted 1.25 mm in cranial direction from the intended position, when the BrainLAB Target Positioner for Leksell Headring Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be provided to the customers to correct the problem, estimated to be available in September 2007. Any questions were directed to their local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.

Device

Device Recall BrainLAB Target Positioner for Leksell Headring
  • Modelo / Serial
    Catalog/version number 40700-3A, all serial numbers
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Ohio, Washington and France
  • Descripción del producto
    BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Dirección del fabricante
    Brainlab AG, Ammerthalstrasse 8, Kirchheim B. Muenchen Germany
  • Source
    USFDA