FDADecember 24, 2025device
GE 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
What to do
FDA enforcement status: Ongoing
Brands named
ge medical systems israel functional imaging
UPCs
00195278454218001952785923090019527879282200195278901439
Recall history
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