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Brainlab AG recalls AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tom
Recalled February 14, 2018 · FDA recall Z-0509-2018 · Brainlab AG
Hazard
Risk of unintended motion while the AIRO system is in transport mode. · FDA Class II
Units
102
Sold at
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.
Description
Risk of unintended motion while the AIRO system is in transport mode.
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).
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →