Retiro De Equipo (Recall) de Device Recall Siemens Artis zee 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación 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
    System, x-ray, angiographic - Product Code IZI
  • Causa
    The firm became aware of a potential issue with artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
  • Acción
    Siemens sent an letter to all affected customers in January 2013, notifying them of the potential issue and urging customers to make appointments with Siemens to have software update AX 027/12/S realized in order to resolve the problem. The software update was made available from January 22, 2013, on. Customers were also asked to pass along this information if the device was no longer in their possession. The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 17 unit(s) will consist of the following: 1. The firm sent out a customer notification letter in January 2013 notifying them of the issue and highlighting the approved procedures of the Corrective Action Plan. 2. Siemens directed in the customer notification letter, for the end-user to make an appointment with the Customer Service organization to have safety update AX 027/12/S realized. 3. As stated in the safety update AX 027/12/S and in the e-mail response the update to correct this issue will be provided to the customer at no expense. 4. Siemens indicated in the customer notification letter that the AX 027/12/S update will be made available from January 22, 2013 and on. 5. The AX 027/12/S update provides general information, work instructions and a completion certificate on how to correct the dislocated scatter radiation filter inside the collimator. You may proceed with implementation of the CAP (subject to the conditions noted above). For further questions please call (610) 219-6300.


  • Modelo / Serial
    model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
  • Descripción del producto
    Artis zee systems || x-ray, angiographic system
  • Manufacturer


  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
  • Source