Events

Retiro De Equipo (Recall) de Device Recall Phoenix micromelx and nanomelx 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
    73364
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1231-2016
  • Fecha de inicio del evento
    2015-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143968
  • 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
    Ge inspection technologies, lp ("ge") has discovered that certain of its cabinet x-ray systems may not fully comply with the food and drug administration's (fda) cabinet x¿ ray system performance standards, 21 c.F.R. ¿ 1020.40(c)(1)(i).
  • Acción
    GE Inspection Technologies Planned Action to bring into Compliance: 1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013. 2. A second notification of customers with affected systems will be sent within 5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair. 3. Repairs will be completed within 120 days after approval of this CAP and will be made free of charge. For further questions, please call (717) 447-1278. ;

Device

Device Recall Phoenix micromelx and nanomelx cabinet xray systems
  • Modelo / Serial
    phoenix micrornelx and nanomelx cabinet x-ray systems
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.
  • Descripción del producto
    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
  • 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