Retiro De Equipo (Recall) de Device Recall Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5

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 Digisonics, Inc.

¿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
    58421
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2193-2011
  • Fecha de inicio del evento
    2009-02-06
  • Fecha de publicación del evento
    2011-05-13
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Left ventricle volume was inaccurate when the volumes were measured from images having different scales.
  • Acción
    The firm, Digisonics, notified consignees/customers via e-mail entitled "Distribution of Notification of Biplane Error" dated February 6, 2009. The email described the product, problem and actions to be taken. The customers were instructed to immediately contact Digisonics if their site calculates biplane volumes-a utility will be provided which will run on their database and identify all studies in which biplane volumes are calculated. The customers were also instructed to share the following important information with all users of DigiView at their site. The email stated -until the software patch has been installed, biplane volumes should be calculated only from pairs of images having the same depth scale. Replacement DigiView/ERS software that prevents further occurrence of this problem will be provided if it appears their site could be impacted. The Distribution of New Software Release was sent on March 6, 2009. If you have any questions, please call Digisonics Customer Support at 800-344-4266

Device

  • Modelo / Serial
    DigiView software release numbers 3.6.44, 3.6.4.6, and 3.6.5
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.
  • Descripción del producto
    Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 || Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Digisonics, Inc, 3701 Kirby Dr Ste 930, Houston TX 77098-3922
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA