Airo Mobile Intraoperative CT I Airo — Class II medical device recall Z-1016-2015
Terminated recall by Mobius Imaging, LLC, reported 2015-02-04, distributed in AK, CA, IL, MA, NC, NY, PA, TX…. There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Su
| Recall number | Z-1016-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mobius Imaging, LLC, Ayer, MA, United States |
| Recall initiated | 2014-12-08 |
| Classified | 2015-01-27 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2015-07-06 |
| Distributed | AK, CA, IL, MA, NC, NY, PA, TX, WA, WV |
| Countries outside the US | BE, CH, DE, EG, NL, SA |
| Serial numbers | 2251 |
| Model numbers | MOBICT-32 |
Product
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Reason for recall
There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.
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-1016-2015. 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.