Events

Retiro De Equipo (Recall) de Device Recall Minicat CT Scanner

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 Xoran Technologies, 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
    66338
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0038-2014
  • Fecha de inicio del evento
    2010-07-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122077
  • 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, tomography, computed - Product Code JAK
  • Causa
    The minicat ct scanners subject to this notification failed to meet xoran's specifications for dose rate of 125 ¿ 3 kvp. these 18 complaints received include dose rates both on the high and low end of xoran's specifications. see attachment 1 for details. (e) a n evaluation of the hazards reasonably related to defect or the failure to comply with the federal standard; an evaluation of the health ha.
  • Acción
    All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.

Device

Device Recall Minicat CT Scanner
  • Modelo / Serial
    minicat
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US nationwide
  • Descripción del producto
    Xoran Minicat00158
  • Manufacturer
    Xoran Technologies, Inc.

Manufacturer

Xoran Technologies, Inc.
  • Dirección del fabricante
    Xoran Technologies, Inc., 5210 S State Rd, Ann Arbor MI 48108-7936
  • Empresa matriz del fabricante (2017)
    Xoran Technologies LLC
  • Source
    USFDA