FDAAugust 1, 2018device
AIRO Mobile CT System Model # MobiCT-32
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
mobius imagingmobius
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global...2025-12-24
- FDASMV BodyTrack, System, Tomography, Computed, Emission2025-12-10
- FDASMV DSI, System, Tomography, Computed, Emission2025-12-10
- FDAMAXXUS, System, Tomography, Computed, Emission2025-12-10
- FDASMV DSX New Line, System, Tomography, Computed, Emission2025-12-10
- FDABrand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the o...2025-12-08
- FDADetachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.2025-12-04
- FDADetachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.2025-12-04
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