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U.S. Department of Health and Human Services

Class 2 Device Recall Mobius Imaging Airo Mobile CT System

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  Class 2 Device Recall Mobius Imaging Airo Mobile CT System see related information
Date Initiated by Firm September 26, 2017
Create Date February 24, 2018
Recall Status1 Terminated 3 on August 16, 2018
Recall Number Z-0715-2018
Recall Event ID 79159
510(K)Number K160126  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product 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).
Code Information Requested.
Recalling Firm/
Mobius Imaging, LLC
2 Shaker Rd Ste F100
Shirley MA 01464-2535
For Additional Information Contact Michael Flynn
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
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.
Quantity in Commerce 105
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Mobius Imaging