FDADecember 4, 2025device
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
What to do
FDA enforcement status: Ongoing
Brands named
mobius imagingmobius
UPCs
0086934600020070012813904392
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 DSX New Line, System, Tomography, Computed, Emission2025-12-10
- FDASMV BodyTrack, System, Tomography, Computed, Emission2025-12-10
- FDASMV DSI, System, Tomography, Computed, Emission2025-12-10
- FDAMAXXUS, 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
- FDAIMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio2025-09-30
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