Company:Mobius Imaging, LLC..
Date of Enforcement Report 9/26/2018
Class II:
PRODUCT
AIRO Mobile CT System Model # Mobi CT-32
Recall Number: Z-2991-2018
REASON
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..
RECALLING FIRM/MANUFACTURER
Mobius Imaging, LLC Shirley, MA on 8/1/2018 FDA Mandated: Recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
147
DISTRIBUTION
Nationally and Internationally.