Events

Recall of Mobius Imaging Airo Mobile CT System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mobius Imaging, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79159
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-2018
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161461
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    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.
  • Action
    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
  • Model / Serial
    Requested.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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
  • Manufacturer Address
    Mobius Imaging, LLC, 2 Shaker Rd Ste F100, Shirley MA 01464-2535
  • Manufacturer Parent Company (2017)
    Mobius Imaging LLC
  • Source
    USFDA