Retiro De Equipo (Recall) de Device Recall DigiView software

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
    58400
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2166-2011
  • Fecha de inicio del evento
    2008-11-04
  • Fecha de publicación del evento
    2011-05-10
  • 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
    Failure of software to update some measurements when tracings or points are amended after measurement calculations have been performed.
  • Acción
    Digisonics, Inc., notified consignees by telephone and e-mail on 10/17/2008, informing them that a problem had been found in the Save Linked Images functionality of DigiView Release 3.6 (and all releases which start with 3.6 such as 3.6.1.). The problem is the failure of the software to update some measurements when tracings or points are amended after measurement calculations have been performed. A utility program, called Linked Image Measurement Verify was being supplied to all sites as a patch to the DigiView program. Release 3.6.6 was to be provided to all customers having previous 3.6 version. Problem was fixed in version 3.6.6 and 3.7.1. If you have any questions, please contact Digisonics Customer Support at (800) 940-3240.

Device

  • Modelo / Serial
    DigiView software release numbers 3.6.4.4, 3.6.4.6, and 3.6.5.2
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including States of : TX, OH, NC, MA, NY, IL, FL, OK, MO, ID, AZ, AR, MI CA, MD, and country of Canada. *** Due to the age of this recall, district is recommending no audit checks***
  • Descripción del producto
    DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240. || Digiview is a digital image management and reporting system with an associated clinical database. It provides capture, review and storage of images together with report creation and data basing.
  • Manufacturer

Manufacturer

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