Events

Retiro De Equipo (Recall) de Device Recall Brainlab Diital Lightbox

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
    68737
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2134-2014
  • Fecha de inicio del evento
    2014-06-27
  • Fecha de publicación del evento
    2014-07-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128583
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    The following defects have been identified for data loaded with patient data manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) when loading non-square pixel image data with pdm 2.0, the data set is not correctly transferred and displayed in the corresponding brainlab navigation or planning software. when a data set is loaded, the pixels of the data set are sorted in order to.
  • Acción
    FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated June 27, 2014 were sent to all direct accounts. The letters instruct product users to not upload image data sets with non-square pixels and to verify with their radiology department the modalities of the different imaging devices (e.g. CT, MRT, PET, ultrasound) from which data may be loaded onto a Brainlab device. Brain lab will provide a software update with this issue solved to affected customers with a tentative planned time line of availability being July 2014. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab Diital Lightbox
  • Modelo / Serial
    Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2.   Software Versions: 2.0.0, 2.0.1, and 2.0.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.
  • Manufacturer
    Brainlab AG

Manufacturer

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