Events

Retiro De Equipo (Recall) de Device Recall Syngo.plaza Picture Archiving and communications systems

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
    76639
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1533-2017
  • Fecha de inicio del evento
    2017-02-20
  • Fecha de publicación del evento
    2017-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153715
  • 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
    Software updates.
  • Acción
    Siemens mailed a notification letter dated February 21, 2017 to affected customers to inform them of the software updates that were now available to address several issues. Customers were advised to follow the instructions in the notice and where necessary promptly notify and instruct all their staff at their organization who have to be aware of the problem. Customers were also instructed to forward the information to new owners where possible. For questions regarding this recall call 610-219-4834.

Device

Device Recall Syngo.plaza Picture Archiving and communications systems
  • Modelo / Serial
    Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA
  • Descripción del producto
    Syngo.plaza, Picture Archiving and Communications System (PACS) || Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
  • 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