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

PET scanners recalled over a streaking artifact in clinical images

GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.

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: Scored 3 under the risk-of-harm criterion: an artifact in clinical scan images can affect the images a clinician reads, and no injuries are reported.

Plain-English summary

The GE HealthCare Omni Legend is being recalled by GE Medical Systems Israel, Functional Imaging. The record lists the system under names including OMNI Legend 16, Omni Legend 21, OMNI Legend 32 and a range of Omni Legend PET Gantry configurations set out in the enforcement record.

The record states there is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images, and that this streaking artifact is most easily identified in transaxial slices on the acquisition console, both corrected and non-corrected for attenuation.

The record lists 364 units, with UDI codes and manufacturing lot or serial numbers recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and a wide range of other countries listed in the record. The FDA has classified the action as Class II.

An artifact in a clinical scan image affects the image a clinician reads. The enforcement record reports no injuries. Facilities should follow GE HealthCare's instructions.

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 — PET scanner
Hazard
Affected units
364

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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