MobiCT-32 AIRO Mobile CT Scanner — Class II medical device recall Z-0957-2023
Ongoing recall by Mobius Imaging, LLC, reported 2023-01-25, distributed nationwide. Stryker received one report of an injury to an untrained user that occurred while the untrained user was movin
| Recall number | Z-0957-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mobius Imaging, LLC, Shirley, MA, United States |
| Recall initiated | 2022-12-07 |
| Classified | 2023-01-17 |
| Reported by FDA | 2023-01-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, DE, DK, DZ, EG, ES, FR, GB, IN, IT, JP, KR, KW, LT, MA, MX, MY, NL, NO, NP, PK, PL, SA, TR, VN |
| Quantity | 303 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00869346000200 |
| Serial numbers | MOBICT-32 |
| Model numbers | MOBICT-32 |
Product
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Reason for recall
Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.
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-0957-2023. 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.