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-0509-2018 · Posted None
Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeJAK
Date Initiated2017-07-28
Date Terminated2018-07-25
Product Quantity102
Reason for Recall
Risk of unintended motion while the AIRO system is in transport mode.
Firm Action
AIRO customers were issued Field Safety Notices dated June 29, 2017. The letter identified the affected product, problem and actions to be taken. A warning label was provided to be placed on the system. For questions contact your local Brainlab Customer Support Representative.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.
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.