Retiro De Equipo (Recall) de Device Recall EOS System X ray beam

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 EOS Imaging.

¿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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    Eos imaging discovered during production internal testing that the x-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the x-ray beam operated by the eos system during the x-ray acquisition.
  • Acción
    CDRH approves the following conditions for EOS Imaging SA: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator notes below what are to be included in the notification. The draft letter provided on November 28, 2013, is deficient for the following reasons: a. It does not provide a statement that all repairs will be made without charge (21 CFR 1003.21(3)). b. It does not provide instructions, with respect to the use of the product pending the correction of the defect (21 CFR 1003.21(1). Specifically, the letter should include directions for the user to determine if the collimation defect is currently present in their system, which would initiate immediate correction, rather than at the next semi-annual service. 2. The customer notification letter will be sent in the manner required by 21 CFR 1003.21(b). 3. The repairs outlined are to be completed by July 1, 2014. All systems under service contracts (which includes semi-annual service) would be visited between receipt of this letter and July 1, 2014. All repairs, including those to systems which are not under service contracts, are also expected to be completed by July 1, 2014. EOS may proceed with implementation of the CAP (subject to the conditions noted above. The customer notification letter may be sent out immediately upon addressing the above deficiencies. However, it is suggested that you provide a copy of the revised letter to FDA for approval prior to issuance. For further questions please call (678) 564-5400.


  • Modelo / Serial
    EOS System
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    EOS System X- ray beam || Digital radiography system used in general radiographic examinations.
  • Manufacturer


  • Dirección del fabricante
    EOS Imaging, 10 rue Mercoeur 4 Ieme Etage, Paris France France
  • Empresa matriz del fabricante (2017)
  • Source