AIRO Mobile CT System — Class II medical device recall Z-0509-2018
Terminated recall by Brainlab AG, reported 2018-02-14, distributed nationwide. Risk of unintended motion while the AIRO system is in transport mode.
| Recall number | Z-0509-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2017-07-28 |
| Classified | 2018-02-02 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, DE, EG, ES, FR, IN, IT, JP, LT, NL, SA |
| Quantity | 102 |
| Serial numbers | AIRO-0106, AIRO-0107-R, AIRO-0108, AIRO-0109, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0121, AIRO-0122, AIRO-0124, AIRO-0125, AIRO-0126, AIRO-0127, AIRO-0128, AIRO-0129, AIRO-0130, AIRO-0131 and 77 more |
| Model numbers | MOBICT-32 |
Product
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
Reason for recall
Risk of unintended motion while the AIRO system is in transport mode.
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-0509-2018. 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.