Events

Retiro De Equipo (Recall) de Device Recall Nebion HLX8 magnetic resonance

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 Nebion, LLC.

¿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
    48967
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2464-2008
  • Fecha de inicio del evento
    2008-06-25
  • Fecha de publicación del evento
    2008-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72426
  • 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
  • Causa
    Device is mislabeled as a medical device, and has not been properly registered or approved as a medical device by the fda.
  • Acción
    Nebion LLC contacted each holder of a device by telephone on July 2, 2008, and then mailed the recall letter titled URGENT MEDICAL DEVICE RECALL FOR NEBION HLX-8 by with attached recall response form. The customers were requested to completed the questionnaire (recall response form) and mail or fax it back to the company. The Letter instructed customers to stop using the device immediately and contact Nebion to have the device picked up at Nebion's expense by UPS. They were also instructed to report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax (information given regarding the FDA's MedWatch program). If you have questions, contact David LaPoint at 714-614-3141.

Device

Device Recall Nebion HLX8 magnetic resonance
  • Modelo / Serial
    Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion HLX-8
  • Distribución
    Nationwide to CA, FL, HI, and RI.
  • Descripción del producto
    Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion H LX-8
  • Manufacturer
    Nebion, LLC

Manufacturer

Nebion, LLC
  • Dirección del fabricante
    Nebion, LLC, 6060 Center Dr Ste 700, Los Angeles CA 90045-1587
  • Source
    USFDA