FDA-Device2018-03-07Class II
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).
Mobius Imaging, LLC
Hazard
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.
Sold states
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
Affected count
105
Manufactured in
2 Shaker Rd Ste F100, N/A, Shirley, MA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2018Don't want to check this manually?
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