AIRO Mobile CT System Model # MobiCT-32
- Company
- Mobius Imaging, Llc
- Recall Initiated
- August 1, 2018
- Terminated
- December 13, 2019
- Recall Number
- Z-2991-2018
- Quantity
- 147
- Firm Location
- Shirley, MA
Reason for Recall
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.
Distribution
US and foreign distribution.
Lot / Code Info
Model # MobiCT-32
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Mobius Imaging, LLC sent an URGENT MEDICAL DEVICE RECALL letter to customers advising that a voluntary recall related to the AIRO Mobile CT System was initiated. The letter included the reason for the recall and actions to be taken by the customers.
More recalls by Mobius Imaging, Llc
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Jan 9, 2026
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Jan 9, 2026
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Jan 17, 2023