Events

Retiro De Equipo (Recall) de Device Recall SOMATOM Definition AS

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
    74840
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2624-2016
  • Fecha de inicio del evento
    2016-07-13
  • Fecha de publicación del evento
    2016-08-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148568
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    Due to an internal communication error between the firmware and the software of the components, the planned ct scan executes properly, but the injector is not started. therefore, the contrast agent is not injected and the desired examination result is not achieved. this error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
  • Acción
    Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.

Device

Device Recall SOMATOM Definition AS
  • Modelo / Serial
    Model # 10430603 Serial # 74192
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to: MI, NY, CA, KY, ND, NE
  • Descripción del producto
    SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
  • 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