Retiro De Equipo (Recall) de Device Recall Medtronic Oarm Imaging 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 Medtronic Navigation, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • Causa
    Review of on-system electronic product labeling and instructions for comply with applicable use in response to a customer inquiry uncovered gaps in compliance fda standards with the requirements for information to be provided to users in 21cfr 1020.30(h).
  • Acción
    Medtronic Navigation Inc. issued Notiifcation on 3/4/14 and included thee errata sheet to all affected customers updating the missing and incorrect information and ensure that labeling is now in compliance with 21 CFR Part 1020.30(h). This will be followed by a software update that contains the same information on the errata sheet, which serves to correct the electronic version of the Instructions for Use. The paper errata sheet will be sent via traceable means and the software upgrade will be performed by Medtronic Service either through remote access or by site visit of Medtronic service personnel. For further questions please call (978) 698-6000.


  • Modelo / Serial
    Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA (nationwide) Distribution
  • Descripción del producto
    Medtronic O-arm Imaging System Mobile X-ray system. || Model No. BI-700-00027 and BI-700-00028 || The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
  • Manufacturer


  • Dirección del fabricante
    Medtronic Navigation, Inc., 300 Foster St, Littleton MA 01460-2017
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source