Events

Retiro De Equipo (Recall) de Device Recall DRX Revolution Mobile XRay 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 Carestream Health, 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
    65805
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0090-2014
  • Fecha de inicio del evento
    2013-07-26
  • Fecha de publicación del evento
    2013-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120273
  • 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, mobile - Product Code IZL
  • Causa
    During an audit, carestream discovered a drx-1 system that captured an image which displayed an artifact. this issue was discovered in manufacturing. it occurs when the drx product console software is updated to v5.6b software and the detector is not calibrated before use.
  • Acción
    Carestream sent a Urgent-Medical Device Recall letter dated July 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Carestream Health Inc. recently discovered an image artifact issue due to a detector not being recalibrated with the 5.6B software upgrade. As our installation instructions did not require the user to recalibrate during an upgrade, there is a possibility your detector could do the same. When this occurs an image artifact could be evident on images captured in the Extended Exposure mode. These artifacts could potentially contribute to misdiagnosis or the necessity of patient re-exposure. We request that you take a moment to verify that your detector(s) are calibrated. At our next visit, Carestream will also verify that your detector was re-calibrated and, if not, re-calibrate the detector for you. Please note this only affects systems upgraded in the field. For questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910, 8 am through 8 pm EST in the US.

Device

Device Recall DRX Revolution Mobile XRay System
  • Modelo / Serial
    Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.
  • Descripción del producto
    DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 || Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 || The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Dirección del fabricante
    Carestream Health, Inc., 150 Verona Street, Rochester NY 14608-1733
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    USFDA