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Sign in to claim this brandMobius Imaging
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2 Shaker Road, Shirley, MA, 01464
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010151377
- DUNS Number
- —
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Airo® | MobiCT-32 | FDA UDI | Class II | Active |
| Airo Ct System | K131431 | FDA 510(k) | Class II | Active |
| AIRO Computed Tomography (CT) X-ray System | K180393 | FDA 510(k) | Class II | Active |
| AIRO Computed Tomography (CT) X-ray System | K160126 | FDA 510(k) | Class II | Active |
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FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 4, 2025 | Z-1040-2026 | — | open, classified | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. |
| Dec 4, 2025 | Z-1041-2026 | — | open, classified | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. |
| Dec 7, 2022 | Z-0957-2023 | — | open, classified | 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. |
| Nov 18, 2022 | Z-0344-2023 | — | terminated | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing. |
| Aug 1, 2018 | Z-2991-2018 | — | terminated | 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. |
| Sep 26, 2017 | Z-0715-2018 | — | terminated | If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan. |
| Dec 8, 2014 | Z-1016-2015 | — | terminated | 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. |