Mobius Imaging, LLC recalls AIRO Mobile CT System Model # MobiCT-32
Recalled Product
AIRO Mobile CT System Model # MobiCT-32
Hazard / Issue
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.
Issued by
FDA
Distribution: US and foreign distribution.
Lot/Code Info: Model # MobiCT-32
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