Events

Retiro De Equipo (Recall) de Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems.

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 GE Inspection Technologies, LP.

¿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
    74554
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2236-2016
  • Fecha de inicio del evento
    2016-03-02
  • Fecha de publicación del evento
    2016-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147897
  • 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
    Cabinet x-ray, industrial - Product Code RCE
  • Causa
    Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. the identified cause was insufficient attachment of shielding in the door. jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
  • Acción
    GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.

Device

Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems.
  • Modelo / Serial
    SN - PA2384
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : FL, TN, and TX.
  • Descripción del producto
    GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. || A microfocus CT system used primarily for 3D metrology and analysis.
  • Manufacturer
    GE Inspection Technologies, LP

Manufacturer

GE Inspection Technologies, LP
  • Dirección del fabricante
    GE Inspection Technologies, LP, 50 Industrial Park Rd, Lewistown PA 17044-9312
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA