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OmniRecalls & reported problems across all models

GE Medical Systems, L.L.C. · 3 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
1

We found 3 models of Omni by GE Medical Systems, L.L.C. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Omni recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Dec 24, 2025Class IICompleted

    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).

    Z-1112-2026 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗

Omni models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other GE Medical Systems, L.L.C. products

All GE Medical Systems, L.L.C. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page