Events

Retiro De Equipo (Recall) de Device Recall GE Cabinet 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 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
    70478
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1211-2015
  • Fecha de inicio del evento
    2015-01-13
  • Fecha de publicación del evento
    2015-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133876
  • 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
    It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x l240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
  • Acción
    GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These corrections will be made free of charge. The Technical Information Letter used for notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter For further questions, please call (717) 447-1278

Device

Device Recall GE Cabinet Xray system
  • Modelo / Serial
    SN - PA1260
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of OH and PA.
  • Descripción del producto
    GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
  • 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