Events

Retiro De Equipo (Recall) de Device Recall Carestream DRXEvolution with Full Featured (FF) Wall Stand (WS)

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
    67047
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0796-2014
  • Fecha de inicio del evento
    2013-11-25
  • Fecha de publicación del evento
    2014-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124607
  • 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. has issued a recall for the carestream drx-evolution (ff ws and csj ws) and the kodak directview dr 7500 system due to the potential for unexpected device movement.
  • Acción
    The firm, Carestream Health Inc, sent an "URGENT: Medical Device Recall" notice dated November 20, 2013 to their customers. The notice described the product, problem and actions to be taken. The customers were instructed that the Emergency Stop (E-Stop) button be used on the motorized FF WS and CSH WS Buckys for any observed uncontrolled movement as indicated in the user guide. If this movement is observed, please notify Carestream Health, and Carestream will schedule a site visit to resolve the problem. In addition, Carestream Health Inc. will apply a label(s) indicating the location of the E-stop button for customers using the FF WS. If you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910.

Device

Device Recall Carestream DRXEvolution with Full Featured (FF) Wall Stand (WS)
  • Modelo / Serial
    Service Code: 7171
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    DRX-Evolution with FF WS || These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • 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