Mobius Imaging, LLC
Medical device manufacturer in Shirley, MA.
3510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1041-2026 Class II | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray…AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | 12/04/2025Open, Classified |
| Z-1040-2026 Class II | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray…AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | 12/04/2025Open, Classified |
| Z-0957-2023 Class II | 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… | 12/07/2022Open, Classified |
| Z-0344-2023 Class II | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT)…Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass… | 11/18/2022Terminated |
| Z-2991-2018 Class II | AIRO Mobile CT System Model # MobiCT-32The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version… | 08/01/2018Terminated |
| Z-0715-2018 Class II | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be…If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of… | 09/26/2017Terminated |
| Z-1016-2015 Class II | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray…There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided… | 12/08/2014Terminated |