Events

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
    Recall
  • ID del evento
    62571
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2244-2012
  • Fecha de inicio del evento
    2012-07-11
  • Fecha de publicación del evento
    2012-08-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111068
  • 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
    A fault in a high voltage relay in the 0-arm¿ imaging system might cause the relay to overheat and burn.
  • Acción
    Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm¿ Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm¿ Imaging System.

Device

Device Recall Medtronic Oarm Imaging System
  • Modelo / Serial
    Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.
  • Descripción del producto
    Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Dirección del fabricante
    Medtronic Navigation, Inc., 300 Foster St, Littleton MA 01460-2017
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    USFDA