Recall archive / FDA device enforcement
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen... — FDA record Z-1112-2026
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
- Reason
- 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).
- Classification
- Class II
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Quantity
- 364 units
- Agency-reported status
- Completed
- Source record identifier
- Z-1112-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; Omni Legend 21: UDI (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/Serial Number OH4E43002; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/Serial Number OM6E61101; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/Serial Number OM6D61084; OMNI Legend 32: UDI (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/Serial Number OM6C61031; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/Serial Number OM6E61097; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/Serial Number OM6D61072; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/Serial Number NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/Serial Number NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/Serial Number NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/Serial Number NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/Serial Number NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM; Omni Legend PET Gantry 16cm Haifa LM: UDI (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/Serial Number OH3D35002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/Serial Number OW3C32001; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/Serial Number OW3C32002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/Serial Number OW3C32003; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/Serial Number OW3C32006; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/Serial Number OW3C32010; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/Serial Number OW3D32018; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/Serial Number OW3D32021; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/Serial Number OW3D32013; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/Serial Number OW3C32007; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/Serial Number OW3D32020; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/Serial Number OW3D32019; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/Serial Number OW3D32014; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/Serial Number OW3D32015; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/Serial Number OW3C32004; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/Serial Number OW3C32011; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/Serial Number OW3C32005; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/Serial Number OW3C32008; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/Serial Number OW3D32016; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32012(11)240100, Manufacturing Lot/Serial Number OW3D32012; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32009(11)231000, Manufacturing Lot/Serial Number OW3C32009; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3E32022(11)250400, Manufacturing Lot/Serial Number OW3E32022; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241000(21)NL1FG2400003BH, Manufacturing Lot/Serial Number NL1FG2400003BH /CBDDG2400119HM/ C1PMT2400296HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241000(21)NL1FG2400004BH, Manufacturing Lot/Serial Number NL1FG2400004BH /CBDDG2400121HM/ C1PMT2400305HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)241200(21)NL1FG2500001BH, Manufacturing Lot/Serial Number NL1FG2500001BH/ CBDDG2400143HM /C1PMT2300279HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250200(21)NL1FG2500002BH, Manufacturing Lot/Serial Number NL1FG2500002BH/ CBDDG2500009HM/ C1PMT2500018HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250506(21)NL1FG2500003BH, Manufacturing Lot/Serial Number NL1FG2500003BH/ CBDDG2500030HM/ C1PMT2500083HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)240500(21)NL1FG2400001BH, Manufacturing Lot/Serial Number NL1FG2400001BH/ CBDDG2400063HM/ C1PMT2400126HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)240900(21)NL1FG2400002BH, Manufacturing Lot/Serial Number NL1FG2400002BH/ CBDDG2400109HM/ C1PMT2400245HM; Omni Legend PET Gantry 21cm - BJ for Global: UDI (01)00195278792822(11)250509(21)NL1FG2500004BH, Manufacturing Lot/Serial Number NL1FG2500004BH/ CBDDG2500032HM/ C1PMT2500086HM; Omni Legend PET Gantry 21cm - Global Haifa LM: UDI (01)00195278592309(21)OH4E43005(11)250609, Manufacturing Lot/Serial Number OH4E43005; Omni Legend PET Gantry 21cm - Global Haifa LM: UDI (01)00195278592309(21)OH4E43003(11)250300, Manufacturing Lot/Serial Number OH4E43003; Omni Legend PET Gantry 21cm - Mobile: UDI (01)00195278454218(21)OW4D47001(11)241100, Manufacturing Lot/Serial Number OW4D47001; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44003(11)240800, Manufacturing Lot/Serial Number OM4D44003; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44009(11)241100, Manufacturing Lot/Serial Number OM4D44009; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44002(11)240500, Manufacturing Lot/Serial Number OM4D44002; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44006(11)241000, Manufacturing Lot/Serial Number OM4D44006; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44017(11)250528, Manufacturing Lot/Serial Number OM4E44017; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44008(11)241100, Manufacturing Lot/Serial Number OM4D44008; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44005(11)241000, Manufacturing Lot/Serial Number OM4D44005; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44015(11)250512, Manufacturing Lot/Serial Number OM4E44015; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44013(11)250300, Manufacturing Lot/Serial Number OM4E44013; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44010(11)250300, Manufacturing Lot/Serial Number OM4E44010; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44007(11)241100, Manufacturing Lot/Serial Number OM4D44007; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44016(11)250525, Manufacturing Lot/Serial Number OM4E44016; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44001(11)240300, Manufacturing Lot/Serial Number OM4D44001; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4E44011(11)250200, Manufacturing Lot/Serial Number OM4E44011; Omni Legend PET Gantry 21cm WSO LM: UDI (01)00195278454218(21)OM4D44004(11)240900, Manufacturing Lot/Serial Number OM4D44004; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241000(21)NL1DG2400006BH, Manufacturing Lot/Serial Number NL1DG2400006BH /CBDDG2400115HM /C1PMT2400277HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250619(21)NL1DG2500007BH, Manufacturing Lot/Serial Number NL1DG2500007BH/ CBDDG2500042HM/C1PMT2500116HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400003BH, Manufacturing Lot/Serial Number NL1DG2400003BH/ CBDDG2400091HM/ C1PMT2400185HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250521(21)NL1DG2500005BH, Manufacturing Lot/Serial Number NL1DG2500005BH/ CBDDG2500037HM/ C1PMT2500093HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250702(21)NL1DG2500008BH, Manufacturing Lot/Serial Number NL1DG2500008BH/ CBDDG2500043HM/ C1PMT2500121HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250515(21)NL1DG2500004BH, Manufacturing Lot/Serial Number NL1DG2500004BH/ CBDDG2500034HM/ C1PMT2500089HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400002BH, Manufacturing Lot/Serial Number NL1DG2400002BH/ CBDDG2400083HM/ C1PMT2400172HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240700(21)NL1DG2400004BH, Manufacturing Lot/Serial Number NL1DG2400004BH/ CBDDG2400096HM /C1PMT2400197HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250611(21)NL1DG2500006BH, Manufacturing Lot/Serial Number NL1DG2500006BH/ CBDDG2500040HM/ C1PMT2500111HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)231100(21)NL1DG2400001BH, Manufacturing Lot/Serial Number NL1DG2400001BH; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250200(21)NL1DG2500002BH, Manufacturing Lot/Serial Number NL1DG2500002BH/ CBDDG2500015HM/ C1PMT2500053HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241100(21)NL1DG2400007BH, Manufacturing Lot/Serial Number NL1DG2400007BH /CBDDG2400131HM/ C1PMT2400328HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)240800(21)NL1DG2400005BH, Manufacturing Lot/Serial Number NL1DG2400005BH/ CBDDG2400108HM /C1PMT2400226; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)241200(21)NL1DG2400008BH, Manufacturing Lot/Serial Number NL1DG2400008BH/ CBDDG2400142HM/ C1PMT2400342HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250400(21)NL1DG2500003BH, Manufacturing Lot/Serial Number NL1DG2500003BH /CBDDG2500025HM/ C1PMT2500071HM; Omni Legend PET Gantry 32cm - MEA: UDI (01)00195278792822(11)250100(21)NL1DG2500001BH, Manufacturing Lot/Serial Number NL1DG2500001BH/ CBDDG2500007HM/ C1PMT2500012HM; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66004(11)241100, Manufacturing Lot/Serial Number OH6D66004; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66001(11)240200, Manufacturing Lot/Serial Number OH6D66001; Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66002(11... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, United Kingdom, and Uzbekistan.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 28, 2026
- Recall initiation date
- Dec 24, 2025
- Center classification date
- Jan 16, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.