Recall Z-2991-2018 ยท JAK System, X-Ray, Tomography, Computed
Mobius Imaging, LLC
AIRO Mobile CT System Model # MobiCT-32
| Date | Aug 1, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 147 |
| Distribution | US and foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180393 | AIRO Computed Tomography (CT) X-ray System Mobius Imaging, LLC, Mar 15, 2018 |