Official recall record
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm -
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-12-24
- Country of alert
- Israel
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00195278454218
- Brand on record
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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