Home / Recalls / Medical Devices
Mobius Imaging, LLC recalls AIRO Mobile CT System Model # MobiCT-32
Recalled September 26, 2018 · FDA recall Z-2991-2018 · Mobius Imaging
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. · FDA Class II
Units
147
Sold at
US and foreign distribution.
Description
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.
Product
AIRO Mobile CT System Model # MobiCT-32
Manufacturer(s)
Mobius Imaging, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →