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

[pending] 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

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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