Mobius Imaging, LLC
Mobius Imaging, LLC appears in FDA public data with 7 recalls, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1041-2026, Class II) was initiated on December 4, 2025. Its most recent 510(k) clearance was granted on March 15, 2018.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1041-2026 | Class II | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. | December 4, 2025 |
| Z-1040-2026 | Class II | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. | December 4, 2025 |
| Z-0957-2023 | Class II | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. | December 7, 2022 |
| Z-0344-2023 | Class II | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, softwa | November 18, 2022 |
| Z-2991-2018 | Class II | AIRO Mobile CT System Model # MobiCT-32 | August 1, 2018 |
| Z-0715-2018 | Class II | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used f | September 26, 2017 |
| Z-1016-2015 | Class II | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. | December 8, 2014 |