Events

Retiro De Equipo (Recall) de Device Recall KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500

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
    67188
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0844-2014
  • Fecha de inicio del evento
    2013-12-26
  • Fecha de publicación del evento
    2014-01-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124908
  • 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, stationary - Product Code KPR
  • Causa
    Carestream health, inc. has recalled dr 7500 dual detector system utilizing version 5.X software due to a possible patient image display error.
  • Acción
    On December 26, 2013 Carestream Health, Inc. distributed Urgent Medical Device Recall notification letters dated December 19, 2013 to their customers via Fed Ex. Carestream Health, Inc. recommends that once the daily detector calibration process is initiated on the DR 7500 System running Version 5.X software it should not be interrupted. The calibration process should be completed only when patients are not being imaged. A Carestream Health Service representative will contact all customers to install a software modiciation to Version 5.X software which will not allow the cancellation of detector calibration. Customers will questions can call 1-800-328-2910 7 days per week on a 24 hour basis.

Device

Device Recall KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500
  • Modelo / Serial
    Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
  • Descripción del producto
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Dirección del fabricante
    Carestream Health, Inc., 1049 Ridge Rd W, Rochester NY 14615-2731
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    USFDA