Retiro De Equipo (Recall) de Device Recall digital breast tomosynthesis

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Digital breast tomosynthesis - Product Code OTE
  • Causa
    A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. the data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (gpu). if the fatal error message occurs, reconstruction of the data will be aborted. the syste.
  • Acción
    Siemens sent a Field Safety Notice dated February 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. How will the issue finally be resolved? Siemens is releasing a field modification to resolve this issue as soon as possible. The upgrade software (VB30P) will be available to the affected customers free of charge. A Siemens service engineer will contact you to schedule implementation of the modification for your system. According to regulations set forth in 21 CFR 7.49(d), we advise that you follow the instructions in this notice and where necessary request that you promptly notify and instruct all the staff at your organization who have to be aware of this problem. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. We thank you for your cooperation. For further questions, please call (610) 448-6478.


  • Modelo / Serial
    Model number: 10140000
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.
  • Descripción del producto
    Mammomat Inspiration with Tomosynthesis functionality
  • Manufacturer


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