Company:Mobius Imaging, LLC..
Date of Enforcement Report 9/26/2018
AIRO Mobile CT System Model # Mobi CT-32
Recall Number: Z-2991-2018
The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 18.104.22.168, and operators would not be able to detect this fault until after a scan is completed..
Mobius Imaging, LLC Shirley, MA on 8/1/2018 FDA Mandated: Recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationally and Internationally.