Events

Retiro De Equipo (Recall) de Device Recall VeinViewer

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 Christie Medical Holding 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
    61420
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1281-2012
  • Fecha de inicio del evento
    2012-03-14
  • Fecha de publicación del evento
    2012-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108035
  • 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
    Device, vein location, liquid crystal - Product Code KZA
  • Causa
    Instrument may tip over if not moved correctly.
  • Acción
    Christie Medical Holdings, Inc. sent an Urgent Medical Device Correction by letter on March 14, 2012 to all affected customers. The letter identified the product, problem and actions to be taken. The letter includes "Correct Transport" and "Do Not Pull labels to be applied to the unit. Customers were instructed to immediately examine their inventory, quarantine all product subject to correction and apply the labels prior to use. A Service Bulletin is enclosed that should be kept and placed with the User Guide for future reference and a Response Form to be completed and return as soon as possible. For questions contact Technical Service at 901-721-0300.

Device

Device Recall VeinViewer
  • Modelo / Serial
    All codes distributed between 02/11/2008  03/31/2011
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, China, Brazil, Czech Republic, Canada, Germany, Denmark, Spain, Great Britain, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Mexico, Malaysia, Netherlands, Norway, Philippines, Russian Federation, Saudi Arabia, Singapore, Thailand, Turkey, Taiwan, and United Arab Emirates
  • Descripción del producto
    VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx Corporation, Memphis, TN 38104 || Product Usage: CTS Usage: || Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin
  • Manufacturer
    Christie Medical Holding Inc

Manufacturer

Christie Medical Holding Inc
  • Dirección del fabricante
    Christie Medical Holding Inc, 1256 Union Ave, Memphis TN 38104
  • Source
    USFDA