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).
FDA Recall Z-0715-2018 · Posted None
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Recalling FirmMobius Imaging, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2017-09-26
Date Terminated2018-08-16
Product Quantity105
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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