FDA-Device2018-09-26Class II
AIRO Mobile CT System Model # MobiCT-32
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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