The Recall Desk
Severity pendingFDA (Devices)·Z-1112-2026·Announced 2026-01-28

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI L

Pending LLM rewrite. Source: FDA_DEVICE Z-1112-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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).

The recalled product

Product
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
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • OMNI Legend 16: UDI (01)00195278454218(21)OM3D31087(11)240400
  • Manufacturing Lot/Serial Number OM3D31087
  • OMNI Legend 16: UDI (01)00195278454218(21)OM3D31071(11)240200
  • Manufacturing Lot/Serial Number OM3D31071
  • OMNI Legend 16: UDI (01)00195278454218(21)OM3D31100(11)240700
  • Manufacturing Lot/Serial Number OM3D31100
  • OMNI Legend 16: UDI (01)00195278454218(21)OM3E31115(11)250100
  • Manufacturing Lot/Serial Number OM3E31115
  • OMNI Legend 16: UDI (01)00195278592309(21)OH3D35001(11)240600
  • Manufacturing Lot/Serial Number OH3D35001
  • OMNI Legend 16: UDI (01)00195278592309(21)OH3E35003(11)250100
  • Manufacturing Lot/Serial Number OH3E35003
  • Omni Legend 21: UDI (01)00195278454218(21)OM4E44014(11)250400
  • Manufacturing Lot/Serial Number OM4E44014
  • Omni Legend 21: UDI (01)00195278454218(21)OM4E44012(11)250200
  • Manufacturing Lot/Serial Number OM4E44012
  • Omni Legend 21: UDI (01)00195278592309(21)OH4E43004(11)250400
  • Manufacturing Lot/Serial Number OH4E43004
  • Omni Legend 21: UDI (01)00195278592309(21)OH4E43001(11)250100
  • Manufacturing Lot/Serial Number OH4E43001

Distribution

Distributed nationwide across the United States.

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