Events

Retiro De Equipo (Recall) de Mobius Imaging Airo Mobile CT 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 Mobius Imaging, 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
    79159
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0715-2018
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161461
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the ct system is homing the axis at startup or preparing for a scan.
  • Acción
    Mobius sent an Urgent Field Safety Notice letter dated September 26, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Mobius Imaging is advising all customers to discontinue using the AIRO until update is completed on their system. Please provide a copy of this Field Safety Notification to all AIRO operators that use the AIRO system, and quarantine the system per hospital policies and procedures.

Device

Mobius Imaging Airo Mobile CT System
  • Modelo / Serial
    Requested.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan
  • Descripción del producto
    AIRO Mobile CT System, Model Number: MobiCT-32 || Product Usage: || The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
  • Manufacturer
    Mobius Imaging, LLC

Manufacturer

Mobius Imaging, LLC
  • Dirección del fabricante
    Mobius Imaging, LLC, 2 Shaker Rd Ste F100, Shirley MA 01464-2535
  • Empresa matriz del fabricante (2017)
    Mobius Imaging LLC
  • Source
    USFDA