Events

Retiro De Equipo (Recall) de Device Recall syngo Dynamics version 9.0

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
    58545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2293-2011
  • Fecha de inicio del evento
    2011-03-24
  • Fecha de publicación del evento
    2011-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99559
  • 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
    If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "preliminary" watermark displayed.
  • Acción
    The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks. If you have any questions, call +1 (734) 205-2400.

Device

Device Recall syngo Dynamics version 9.0
  • Modelo / Serial
    10091602, 10091604
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.
  • Descripción del producto
    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. || The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.
  • Manufacturer
    Siemens Medical Solutions, USA, Inc

Manufacturer

Siemens Medical Solutions, USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions, USA, Inc, 400 Morgan Rd, Ann Arbor MI 48108
  • Source
    USFDA