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
    65586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0132-2014
  • Fecha de inicio del evento
    2013-06-19
  • Fecha de publicación del evento
    2013-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119661
  • 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
    Carestream health inc. is conducting a recall for the column end cover present on the drx revolution mobile x-ray system due to the cover dislodging from the column.
  • Acción
    The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.

Device

Device Recall DRX Revolution Mobile Xray System
  • Modelo / Serial
    Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
  • Descripción del producto
    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). || 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 St, Rochester NY 14608-1733
  • Empresa matriz del fabricante (2017)
    ONEX Corp
  • Source
    USFDA