FDA-Device2018-09-26Class II
AIRO Mobile CT System Model # MobiCT-32
Mobius Imaging, LLC
Hazard
The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.
Sold states
US and foreign distribution.
Affected count
147
Manufactured in
2 Shaker Rd Ste F100, N/A, Shirley, MA, United States
Products
AIRO Mobile CT System Model # MobiCT-32
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2991-2018Don't want to check this manually?
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