Events

Retiro De Equipo (Recall) de Siemens SOMATOM Force

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
    75594
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0692-2017
  • Fecha de inicio del evento
    2016-10-20
  • Fecha de publicación del evento
    2016-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150867
  • 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
    Siemens is providing software update version va50a_sp3 to address the software bugs that were identified through normal field monitoring and the global complaint handling process. correction for the problems are as follows: 1. correction to volumetric misrepresentations of high contrast objects when using admire. 2. correction to highly sporadic scan aborts due to temporarily tube currents at 0ma. 3. correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4. correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
  • Acción
    Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.

Device

Siemens SOMATOM Force
  • Modelo / Serial
    Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    SOMATOM Force, System x-ray, tomography, computed
  • 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