Events

Retiro De Equipo (Recall) de Device Recall Syngo.via 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 Siemens Medical Solutions USA, 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
    79513
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1261-2018
  • Fecha de inicio del evento
    2018-01-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162538
  • 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
    When the archiving configuration is changed, data received/created after the upgrade may be flagged as "not to be archived". this is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. due to the disabled cleanup function, disc capacity for free space decreases faster than usual. unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
  • Acción
    Customers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install.

Device

Device Recall Syngo.via software
  • Modelo / Serial
    All Syngo.via systems with VB20A. Model number 10496180.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Medical device software which needs to be installed.
  • Descripción del producto
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA