AIRO Mobile CT System Model # MobiCT-32 — Class II medical device recall Z-2991-2018
Terminated recall by Mobius Imaging, LLC, reported 2018-09-26. The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0
| Recall number | Z-2991-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Mobius Imaging, LLC, Shirley, MA, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2018-09-14 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2019-12-13 |
| Quantity | 147 |
| Reason classes | software |
| Model numbers | MOBICT-32 |
Product
AIRO Mobile CT System Model # MobiCT-32
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2991-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.