Events

Retiro De Equipo (Recall) de BrainSCAN and iPlan RT Dose

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
    52988
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2251-2009
  • Fecha de inicio del evento
    2009-08-12
  • Fecha de publicación del evento
    2009-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84397
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • Causa
    Failure to conduct important safety checks when using the brainlab radiotherapy treatment planning software in combination with brainlab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.
  • Acción
    BrainLAB AG issued an "Urgent Field Safety Notice" letter dated August 12, 2009 informing all customers of the BrainLab radiotherapy planning software using conical collimators of the important safety checks to avoid the failure to apply and verify an adequate jaw-shaped field size and field position at the LINAC for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator. Consignees were instructed on proper steps to take to avoid further issues. For further questions, contact BrainLAB AG by phone at 1-800-597-5911. *** On February 1, 2010, BrainLab sent supplemental letters to 50 of the accounts who received the August 12, 2009 letter and have Novalis Dose Delivery Systems (excluding all Novalis Tx systems). The accounts were informed that in addition to the safety checks listed in the August letter, BrainLab will be installing a mandatory software modification on their systems that limits the field size to a maximum of 4x4 cm2 when the conical collimators are inserted. The accounts would be contacted by a service representative within the next six weeks to schedule the update. Any questions were directed to BrainLab at 1-800-597-5911. ***

Device

BrainSCAN and iPlan RT Dose
  • Modelo / Serial
    All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    BrainLab Radiotherapy Treatment Planning Software; || Catalog number 20610 - Radiosurgery 3.0 || Catalog number 20620 - Radiosurgery 3.5 and || Catalog number 20630 - Circular ARC SRS/SRT Planning. || The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.
  • Manufacturer
    Brainlab AG

Manufacturer

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