Data / Medical devices / United States / Mobius Imaging, LLC
Mobius Imaging, LLC: FDA-registered device maker in Shirley, MA, United States, 1 510(k) clearance
Mobius Imaging, LLC is registered with the FDA (registration 3010151377) in Shirley, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 15, 2018. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010151377
- Address
- 2 Shaker Road Suite F100, Shirley, MA, United States, 01464
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Specification developer
- First device listed
- November 5, 2019
- Registered through
- 2027
- Brand names listed
- AIRO Computed Tomography (CT) X-ray System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2018 | K180393 | AIRO Computed Tomography (CT) X-ray System | JAK | Substantially Equivalent | Mobius Imaging, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 4, 2025 | 98099 | Class II | Ongoing | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | accessdata.fda.gov |
| December 7, 2022 | 91258 | Class II | Ongoing | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. | 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. | accessdata.fda.gov |
| November 18, 2022 | 91178 | Class II | Terminated | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 | 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. | accessdata.fda.gov |
| August 1, 2018 | 80867 | Class II | Terminated | AIRO Mobile CT System Model # MobiCT-32 | 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. | accessdata.fda.gov |
| September 26, 2017 | 79159 | Class II | Terminated | 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 a | 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. | accessdata.fda.gov |
| July 28, 2017 | 79009 | Class II | Terminated | 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 a | Risk of unintended motion while the AIRO system is in transport mode. | accessdata.fda.gov |
| December 8, 2014 | 69993 | Class II | Terminated | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. | 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. | accessdata.fda.gov |
Compare with other makers
Updated January 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.