Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Mobius Imaging, LLC with 7 device recalls and 3 510(k) clearances. The most recent is a device recall dated Dec 4, 2025: Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray Sy….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 4, 2025 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.Class II · AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Device recalls |
| Dec 4, 2025 | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.Class II · AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Device recalls |
| Dec 7, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.Class II · Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo | Device recalls |
| Nov 18, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1Class II · Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The fi | Device recalls |
| Aug 1, 2018 | AIRO Mobile CT System Model # MobiCT-32Class II · The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and | Device recalls |
| Mar 15, 2018 | AIRO Computed Tomography (CT) X-ray SystemK180393 · JAK | 510(k) clearances |
| Sep 26, 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applicationClass II · If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or | Device recalls |
| Apr 19, 2016 | AIRO Computed Tomography (CT) X-ray SystemK160126 · JAK | 510(k) clearances |
| Dec 8, 2014 | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.Class II · There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navi | Device recalls |
| Sep 26, 2013 | AIRO CT SYSTEMK131431 · JAK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
