Events

Retiro De Equipo (Recall) de Device Recall EOS system

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 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
    70732
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1460-2015
  • Fecha de inicio del evento
    2015-02-17
  • Fecha de publicación del evento
    2015-05-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134571
  • 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
    When performing calibration, an alert message on the spectral filtration of the x-ray beam may be suppressed. improper filtration of the x-ray beam can then occur in exams set up with copper filtration.
  • Acción
    Planned Action of EOS Imaging Inc.: 1. Install a new acquisition software version, which will prevent use of the system when improper filter positioning is detected. 2. A customer notification letter which includes a statement that EOS Imaging will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following CDRH approves the CAP subject to the following conditions: 1. Provide documentation to show that all filter positioning subassemblies have been replaced, which you state was implemented to prevent improper filter positioning. 2. 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 noted below are to be included in the notification. 3. EOS Imaging will implement this CAP by September 1, 2015. For further questions call (678) 564-5400.

Device

Device Recall EOS system
  • Modelo / Serial
    Model Number - EOS System
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
  • Descripción del producto
    EOS, Digital radiography system used in general radiographic examinations.
  • Manufacturer
    Eos Imaging Inc

Manufacturer

Eos Imaging Inc
  • Dirección del fabricante
    Eos Imaging Inc, 185 Alewife Brook Pkwy Ste 410, Cambridge MA 02138-1104
  • Empresa matriz del fabricante (2017)
    EOS Imaging SA
  • Source
    USFDA