FDA Device recall Z-2991-2018
AIRO Mobile CT System Model # MobiCT-32
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of AIRO Mobile CT System Model # MobiCT-32 by Mobius Imaging, citing 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 afte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2991-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-01 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mobius Imaging |
| Distribution | n/a |
Product
AIRO Mobile CT System Model # MobiCT-32
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.
Identifiers
| code_info | Model # MobiCT-32 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2991-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.