Events

Retiro De Equipo (Recall) de Device Recall DEXIS Imaging Suite

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 Imaging Sciences International, LLC.

¿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
    62830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2463-2012
  • Fecha de inicio del evento
    2012-07-30
  • Fecha de publicación del evento
    2012-09-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111796
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    A condition can occur during renumbering of the patient database using the dexcopy feature. when renumbering is being performed using the dexcopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. in order for this problem to occur several conditions need to be met: 1).
  • Acción
    DEXIS sent a Medical Device Corrective Action letter dated July 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. An Acknowledgement Form was included with the notification that is to be returned by the consignee to the recalling firm. Customers were instructed to call DEXIS Technical Support at 888-883-3947 as soon as possible to have Technical Support review and potentially correct any issues that may have resulted from its use. To request a free-of-charge upgrade kit, customers should email a request to orders@dexis.com. For questions regarding this recall call 215-997-5666,

Device

Device Recall DEXIS Imaging Suite
  • Modelo / Serial
    Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.
  • Descripción del producto
    DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 || Radiological Image Processing System
  • Manufacturer
    Imaging Sciences International, LLC

Manufacturer

Imaging Sciences International, LLC
  • Dirección del fabricante
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA