| | Class 2 Device Recall GE Healthcare |  |
| Date Initiated by Firm | December 24, 2025 |
|---|
| Date Posted | January 16, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1112-2026 |
|---|
| Recall Event ID |
98269 |
| 510(K)Number | K221932 K241665 |
|---|
| Product Classification |
System, tomography, computed, emission - Product Code KPS
|
| 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 |
|---|
| Code Information |
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)240500, Manufacturing Lot/Serial Number OH6D66002;
Omni Legend PET Gantry 32cm Haifa LM: UDI (01)00195278592309(21)OH6D66003(11)241000, Manufacturing Lot/Serial Number OH6D66003;
Omni Legend PET Gantry 32cm Mobile: UDI (01)00195278454218(21)OW6D62001(11)240200, Manufacturing Lot/Serial Number OW6D62001;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31063(11)240100, Manufacturing Lot/Serial Number OM3D31063;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31072(11)240200, Manufacturing Lot/Serial Number OM3D31072;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31064(11)240100, Manufacturing Lot/Serial Number OM3D31064;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31050(11)231100, Manufacturing Lot/Serial Number OM3C31050;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31044(11)231100, Manufacturing Lot/Serial Number OM3C31044;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31058(11)240100, Manufacturing Lot/Serial Number OM3D31058;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31009(11)230200, Manufacturing Lot/Serial Number OM3C31009;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31065(11)240100, Manufacturing Lot/Serial Number OM3D31065;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31040(11)231000, Manufacturing Lot/Serial Number OM3C31040;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31025(11)230600, Manufacturing Lot/Serial Number OM3C31025;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31059(11)240100, Manufacturing Lot/Serial Number OM3D31059;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31069(11)240200, Manufacturing Lot/Serial Number OM3D31069;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31034(11)230800, Manufacturing Lot/Serial Number OM3C31034;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31015(11)230300, Manufacturing Lot/Serial Number OM3C31015;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31021(11)230500, Manufacturing Lot/Serial Number OM3C31021;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31102(11)240700, Manufacturing Lot/Serial Number OM3D31102;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31103(11)240700, Manufacturing Lot/Serial Number OM3D31103;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31061(11)240100, Manufacturing Lot/Serial Number OM3D31061;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31091(11)240500, Manufacturing Lot/Serial Number OM3D31091;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31079(11)240400, Manufacturing Lot/Serial Number OM3D31079;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31006(11)230100, Manufacturing Lot/Serial Number OM3C31006;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31074(11)240200, Manufacturing Lot/Serial Number OM3D31074;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31056(11)240100, Manufacturing Lot/Serial Number OM3D31056;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31042(11)231000, Manufacturing Lot/Serial Number OM3C31042;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31097(11)240600, Manufacturing Lot/Serial Number OM3D31097;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31007(11)230100, Manufacturing Lot/Serial Number OM3C31007;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31053(11)231100, Manufacturing Lot/Serial Number OM3C31053;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31038(11)231000, Manufacturing Lot/Serial Number OM3C31038;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31081(11)240400, Manufacturing Lot/Serial Number OM3D31081;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31062(11)240100, Manufacturing Lot/Serial Number OM3D31062;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31090(11)240500, Manufacturing Lot/Serial Number OM3D31090;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31043(11)231100, Manufacturing Lot/Serial Number OM3C31043;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31075(11)240200, Manufacturing Lot/Serial Number OM3D31075;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31078(11)240400, Manufacturing Lot/Serial Number OM3D31078;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31084(11)240400, Manufacturing Lot/Serial Number OM3D31084;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31028(11)230700, Manufacturing Lot/Serial Number OM3C31028;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31037(11)231000, Manufacturing Lot/Serial Number OM3C31037;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31114(11)241200, Manufacturing Lot/Serial Number OM3D31114;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31104(11)240700, Manufacturing Lot/Serial Number OM3D31104;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31066(11)240100, Manufacturing Lot/Serial Number OM3D31066;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31014(11)230300, Manufacturing Lot/Serial Number OM3C31014;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31027(11)230700, Manufacturing Lot/Serial Number OM3C31027;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31004(11)221200, Manufacturing Lot/Serial Number OM3B31004;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31086(11)240400, Manufacturing Lot/Serial Number OM3D31086;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31024(11)230600, Manufacturing Lot/Serial Number OM3C31024;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31080(11)240400, Manufacturing Lot/Serial Number OM3D31080;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31096(11)240600, Manufacturing Lot/Serial Number OM3D31096;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31047(11)231100, Manufacturing Lot/Serial Number OM3C31047;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31035(11)230800, Manufacturing Lot/Serial Number OM3C31035;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31085(11)240400, Manufacturing Lot/Serial Number OM3D31085;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31011(11)230200, Manufacturing Lot/Serial Number OM3C31011;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31008(11)230200, Manufacturing Lot/Serial Number OM3C31008;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31049(11)231100, Manufacturing Lot/Serial Number OM3C31049;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31073(11)240200, Manufacturing Lot/Serial Number OM3D31073;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31093(11)240500, Manufacturing Lot/Serial Number OM3D31093;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31022(11)230500, Manufacturing Lot/Serial Number OM3C31022;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31101(11)240700, Manufacturing Lot/Serial Number OM3D31101;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31033(11)230800, Manufacturing Lot/Serial Number OM3C31033;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31077(11)240400, Manufacturing Lot/Serial Number OM3D31077;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31105(11)240700, Manufacturing Lot/Serial Number OM3D31105;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31010(11)230200, Manufacturing Lot/Serial Number OM3C31010;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31020(11)230500, Manufacturing Lot/Serial Number OM3C31020;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31005(11)221200, Manufacturing Lot/Serial Number OM3B31005;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31013(11)230300, Manufacturing Lot/Serial Number OM3C31013;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31076(11)240400, Manufacturing Lot/Serial Number OM3D31076;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31088(11)240500, Manufacturing Lot/Serial Number OM3D31088;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31051(11)231100, Manufacturing Lot/Serial Number OM3C31051;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31095(11)240500, Manufacturing Lot/Serial Number OM3D31095;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31055(11)240100, Manufacturing Lot/Serial Number OM3D31055;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31023(11)230500, Manufacturing Lot/Serial Number OM3C31023;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31001(11)220600, Manufacturing Lot/Serial Number OM3B31001;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31029(11)230700, Manufacturing Lot/Serial Number OM3C31029;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31019(11)230500, Manufacturing Lot/Serial Number OM3C31019;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31041(11)231000, Manufacturing Lot/Serial Number OM3C31041;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31016(11)230300, Manufacturing Lot/Serial Number OM3C31016;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31032(11)230800, Manufacturing Lot/Serial Number OM3C31032;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31094(11)240500, Manufacturing Lot/Serial Number OM3D31094;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31089(11)240500, Manufacturing Lot/Serial Number OM3D31089;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31057(11)240100, Manufacturing Lot/Serial Number OM3D31057;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31107(11)240800, Manufacturing Lot/Serial Number OM3D31107;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31036(11)230900, Manufacturing Lot/Serial Number OM3C31036;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31030(11)230700, Manufacturing Lot/Serial Number OM3C31030;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31012(11)230200, Manufacturing Lot/Serial Number OM3C31012;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31083(11)240400, Manufacturing Lot/Serial Number OM3D31083;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31031(11)230800, Manufacturing Lot/Serial Number OM3C31031;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31112(11)241100, Manufacturing Lot/Serial Number OM3D31112;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31110(11)240800, Manufacturing Lot/Serial Number OM3D31110;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31116(11)250100, Manufacturing Lot/Serial Number OM3E31116;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31092(11)240500, Manufacturing Lot/Serial Number OM3D31092;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31113(11)241100, Manufacturing Lot/Serial Number OM3D31113;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31052(11)231100, Manufacturing Lot/Serial Number OM3C31052;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31117(11)250400, Manufacturing Lot/Serial Number OM3E31117;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3B31003(11)221100, Manufacturing Lot/Serial Number OM3B31003;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31070(11)240200, Manufacturing Lot/Serial Number OM3D31070;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31067(11)240200, Manufacturing Lot/Serial Number OM3D31067;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31046(11)231100, Manufacturing Lot/Serial Number OM3C31046;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31048(11)231100, Manufacturing Lot/Serial Number OM3C31048;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31039(11)231000, Manufacturing Lot/Serial Number OM3C31039;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31099(11)240700, Manufacturing Lot/Serial Number OM3D31099;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31098(11)240600, Manufacturing Lot/Serial Number OM3D31098;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31111(11)240900, Manufacturing Lot/Serial Number OM3D31111;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3E31118(11)250500, Manufacturing Lot/Serial Number OM3E31118;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31109(11)240900, Manufacturing Lot/Serial Number OM3D31109;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31108(11)240800, Manufacturing Lot/Serial Number OM3D31108;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31068(11)240200, Manufacturing Lot/Serial Number OM3D31068;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31106(11)240800, Manufacturing Lot/Serial Number OM3D31106;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31054(11)231200, Manufacturing Lot/Serial Number OM3C31054;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31017(11)230500, Manufacturing Lot/Serial Number OM3C31017;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31018(11)230500, Manufacturing Lot/Serial Number OM3C31018;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3C31026(11)230600, Manufacturing Lot/Serial Number OM3C31026;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31060(11)240100, Manufacturing Lot/Serial Number OM3D31060;
OMNI PET Gantry 15cm: UDI (01)00195278454218(21)OM3D31082(11)240400, Manufacturing Lot/Serial Number OM3D31082;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250708(21)OMW152500014PT, Manufacturing Lot/Serial Number OMW152500014PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241004(21)OMW152400004PT, Manufacturing Lot/Serial Number OMW152400004PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241213(21)OMW152400008PT, Manufacturing Lot/Serial Number OMW152400008PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500010PT, Manufacturing Lot/Serial Number OMW152500010PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241106(21)OMW152400006PT, Manufacturing Lot/Serial Number OMW152400006PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250410(21)OMW152500012PT, Manufacturing Lot/Serial Number OMW152500012PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250423(21)OMW152500013PT, Manufacturing Lot/Serial Number OMW152500013PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500009PT, Manufacturing Lot/Serial Number OMW152500009PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)240926(21)OMW152400003PT, Manufacturing Lot/Serial Number OMW152400003PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250310(21)OMW152500011PT, Manufacturing Lot/Serial Number OMW152500011PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241028(21)OMW152400005PT, Manufacturing Lot/Serial Number OMW152400005PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250710(21)OMW152500015PT, Manufacturing Lot/Serial Number OMW152500015PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)241114(21)OMW152400007PT, Manufacturing Lot/Serial Number OMW152400007PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)240919(21)OMW152400002PT, Manufacturing Lot/Serial Number OMW152400002PT;
Omni PET Gantry 15cm - WSO: UDI (01)00195278901439(11)250102(21)OMW152500001PT, Manufacturing Lot/Serial Number OMW152500001PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250623(21)OMC152500008PT, Manufacturing Lot/Serial Number OMC152500008PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250520(21)OMC152500006PT, Manufacturing Lot/Serial Number OMC152500006PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250120(21)OMC152500001PT, Manufacturing Lot/Serial Number OMC152500001PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250325(21)OMC152500005PT, Manufacturing Lot/Serial Number OMC152500005PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250128(21)OMC152500002PT, Manufacturing Lot/Serial Number OMC152500002PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241209(21)OMC152400007PT, Manufacturing Lot/Serial Number OMC152400007PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241120(21)OMC152400004PT, Manufacturing Lot/Serial Number OMC152400004PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241211(21)OMC152400008PT, Manufacturing Lot/Serial Number OMC152400008PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241014(21)OMC152400001PT, Manufacturing Lot/Serial Number OMC152400001PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241018(21)OMC152400002PT, Manufacturing Lot/Serial Number OMC152400002PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250228(21)OMC152500003PT, Manufacturing Lot/Serial Number OMC152500003PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250321(21)OMC152500004PT, Manufacturing Lot/Serial Number OMC152500004PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241023(21)OMC152400003PT, Manufacturing Lot/Serial Number OMC152400003PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241125(21)OMC152400005PT, Manufacturing Lot/Serial Number OMC152400005PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)241204(21)OMC152400006PT, Manufacturing Lot/Serial Number OMC152400006PT;
OMNI PET Gantry 15cm Cardiac- WSO: UDI (01)00195278901439(11)250612(21)OMC152500007PT, Manufacturing Lot/Serial Number OMC152500007PT;
OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250408(21)OMD152500004PT, Manufacturing Lot/Serial Number OMD152500004PT;
OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250304(21)OMD152500003PT, Manufacturing Lot/Serial Number OMD152500003PT;
OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250218(21)OMD152500002PT, Manufacturing Lot/Serial Number OMD152500002PT;
OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250603(21)OMD152500006PT, Manufacturing Lot/Serial Number OMD152500006PT;
OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250410(21)OMD152500005PT, Manufacturing Lot/Serial Number OMD152500005PT;
OMNI PET Gantry 15cm ES - WSO: UDI (01)00195278901439(11)250213(21)OMD152500001PT, Manufacturing Lot/Serial Number OMD152500001PT;
Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)241217(21)OMM152400001PT, Manufacturing Lot/Serial Number OMM152400001PT;
Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)250206(21)OMM152500001PT, Manufacturing Lot/Serial Number OMM152500001PT;
Omni PET Gantry 15cm Mobile WSO: UDI (01)00195278901439(11)250410(21)OMM152500002PT, Manufacturing Lot/Serial Number OMM152500002PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250617(21)OMW212500007PT, Manufacturing Lot/Serial Number OMW212500007PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250220(21)OMW212500001PT, Manufacturing Lot/Serial Number OMW212500001PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250604(21)OMW212500006PT, Manufacturing Lot/Serial Number OMW212500006PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250519(21)OMW212500004PT, Manufacturing Lot/Serial Number OMW212500004PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250501(21)OMW212500003PT, Manufacturing Lot/Serial Number OMW212500003PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250313(21)OMW212500002PT, Manufacturing Lot/Serial Number OMW212500002PT;
Omni PET Gantry 21cm - WSO: UDI (01)00195278901439(11)250529(21)OMW212500005PT, Manufacturing Lot/Serial Number OMW212500005PT;
Omni PET Gantry 21cm Mobile - WSO: UDI (01)00195278901439(11)250710(21)OMM212500001PT, Manufacturing Lot/Serial Number OMM212500001PT;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61041(11)230900, Manufacturing Lot/Serial Number OM6C61041;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61020(11)230500, Manufacturing Lot/Serial Number OM6C61020;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61010(11)221100, Manufacturing Lot/Serial Number OM6B61010;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61070(11)240600, Manufacturing Lot/Serial Number OM6D61070;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61050(11)231100, Manufacturing Lot/Serial Number OM6C61050;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61053(11)231100, Manufacturing Lot/Serial Number OM6C61053;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61083(11)240800, Manufacturing Lot/Serial Number OM6D61083;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61021(11)230500, Manufacturing Lot/Serial Number OM6C61021;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61019(11)230500, Manufacturing Lot/Serial Number OM6C61019;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61065(11)240500, Manufacturing Lot/Serial Number OM6D61065;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61045(11)231000, Manufacturing Lot/Serial Number OM6C61045;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61024(11)230500, Manufacturing Lot/Serial Number OM6C61024;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61066(11)240500, Manufacturing Lot/Serial Number OM6D61066;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61040(11)230800, Manufacturing Lot/Serial Number OM6C61040;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61077(11)240800, Manufacturing Lot/Serial Number OM6D61077;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61028(11)230700, Manufacturing Lot/Serial Number OM6C61028;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61026(11)230600, Manufacturing Lot/Serial Number OM6C61026;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61058(11)240100, Manufacturing Lot/Serial Number OM6D61058;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61022(11)230500, Manufacturing Lot/Serial Number OM6C61022;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61068(11)240500, Manufacturing Lot/Serial Number OM6D61068;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61012(11)230100, Manufacturing Lot/Serial Number OM6B61012;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61037(11)230800, Manufacturing Lot/Serial Number OM6C61037;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61075(11)240700, Manufacturing Lot/Serial Number OM6D61075;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61025(11)230600, Manufacturing Lot/Serial Number OM6C61025;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61032(11)230700, Manufacturing Lot/Serial Number OM6C61032;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61004(11)221000, Manufacturing Lot/Serial Number OM6B61004;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61056(11)231200, Manufacturing Lot/Serial Number OM6C61056;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61059(11)240100, Manufacturing Lot/Serial Number OM6D61059;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61091(11)241000, Manufacturing Lot/Serial Number OM6D61091;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61087(11)240900, Manufacturing Lot/Serial Number OM6D61087;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61048(11)231000, Manufacturing Lot/Serial Number OM6C61048;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61099(11)250200, Manufacturing Lot/Serial Number OM6E61099;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61023(11)230500, Manufacturing Lot/Serial Number OM6C61023;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61036(11)230800, Manufacturing Lot/Serial Number OM6C61036;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61067(11)240500, Manufacturing Lot/Serial Number OM6D61067;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61029(11)230700, Manufacturing Lot/Serial Number OM6C61029;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61057(11)240100, Manufacturing Lot/Serial Number OM6D61057;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61096(11)250100, Manufacturing Lot/Serial Number OM6E61096;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61076(11)240700, Manufacturing Lot/Serial Number OM6D61076;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61030(11)230700, Manufacturing Lot/Serial Number OM6C61030;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61069(11)240600, Manufacturing Lot/Serial Number OM6D61069;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61042(11)230900, Manufacturing Lot/Serial Number OM6C61042;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61035(11)230700, Manufacturing Lot/Serial Number OM6C61035;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61062(11)240300, Manufacturing Lot/Serial Number OM6D61062;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61080(11)240800, Manufacturing Lot/Serial Number OM6D61080;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61054(11)231100, Manufacturing Lot/Serial Number OM6C61054;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61071(11)240600, Manufacturing Lot/Serial Number OM6D61071;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61085(11)240900, Manufacturing Lot/Serial Number OM6D61085;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61078(11)240800, Manufacturing Lot/Serial Number OM6D61078;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61064(11)240400, Manufacturing Lot/Serial Number OM6D61064;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61090(11)241000, Manufacturing Lot/Serial Number OM6D61090;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61033(11)230700, Manufacturing Lot/Serial Number OM6C61033;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61100(11)250400, Manufacturing Lot/Serial Number OM6E61100;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61011(11)221200, Manufacturing Lot/Serial Number OM6B61011;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61095(11)241200, Manufacturing Lot/Serial Number OM6D61095;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61104(11)250612, Manufacturing Lot/Serial Number OM6E61104;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61073(11)240700, Manufacturing Lot/Serial Number OM6D61073;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61081(11)240800, Manufacturing Lot/Serial Number OM6D61081;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61038(11)230800, Manufacturing Lot/Serial Number OM6C61038;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61008(11)221100, Manufacturing Lot/Serial Number OM6B61008;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61039(11)230800, Manufacturing Lot/Serial Number OM6C61039;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61074(11)240700, Manufacturing Lot/Serial Number OM6D61074;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61013(11)230100, Manufacturing Lot/Serial Number OM6C61013;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61014(11)230100, Manufacturing Lot/Serial Number OM6C61014;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61047(11)231000, Manufacturing Lot/Serial Number OM6C61047;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61034(11)230700, Manufacturing Lot/Serial Number OM6C61034;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61015(11)230100, Manufacturing Lot/Serial Number OM6C61015;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61006(11)221000, Manufacturing Lot/Serial Number OM6B61006;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61055(11)231100, Manufacturing Lot/Serial Number OM6C61055;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61061(11)240200, Manufacturing Lot/Serial Number OM6D61061;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61005(11)221000, Manufacturing Lot/Serial Number OM6B61005;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61051(11)231100, Manufacturing Lot/Serial Number OM6C61051;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61043(11)231000, Manufacturing Lot/Serial Number OM6C61043;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61094(11)241100, Manufacturing Lot/Serial Number OM6D61094;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61102(11)250400, Manufacturing Lot/Serial Number OM6E61102;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61079(11)240800, Manufacturing Lot/Serial Number OM6D61079;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61018(11)230400, Manufacturing Lot/Serial Number OM6C61018;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61009(11)221100, Manufacturing Lot/Serial Number OM6B61009;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61093(11)241100, Manufacturing Lot/Serial Number OM6D61093;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61044(11)231000, Manufacturing Lot/Serial Number OM6C61044;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61103(11)250603, Manufacturing Lot/Serial Number OM6E61103;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61001(11)220500, Manufacturing Lot/Serial Number OM6B61001;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61007(11)221100, Manufacturing Lot/Serial Number OM6B61007;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61063(11)240400, Manufacturing Lot/Serial Number OM6D61063;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61098(11)250200, Manufacturing Lot/Serial Number OM6E61098;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61016(11)230300, Manufacturing Lot/Serial Number OM6C61016;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61082(11)240800, Manufacturing Lot/Serial Number OM6D61082;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61086(11)240900, Manufacturing Lot/Serial Number OM6D61086;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61092(11)241000, Manufacturing Lot/Serial Number OM6D61092;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61049(11)231000, Manufacturing Lot/Serial Number OM6C61049;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6B61002(11)220800, Manufacturing Lot/Serial Number OM6B61002;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61046(11)231000, Manufacturing Lot/Serial Number OM6C61046;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61089(11)241000, Manufacturing Lot/Serial Number OM6D61089;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6D61088(11)241000, Manufacturing Lot/Serial Number OM6D61088;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61017(11)230300, Manufacturing Lot/Serial Number OM6C61017;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6C61052(11)231100, Manufacturing Lot/Serial Number OM6C61052;
OMNI PET Gantry 30cm: UDI (01)00195278454218(21)OM6E61105(11)250520, Manufacturing Lot/Serial Number OM6E61105;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241017(21)OMW302400002PT, Manufacturing Lot/Serial Number OMW302400002PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250115(21)OMW302500002PT, Manufacturing Lot/Serial Number OMW302500002PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250624(21)OMW302500012PT, Manufacturing Lot/Serial Number OMW302500012PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250502(21)OMW302500011PT, Manufacturing Lot/Serial Number OMW302500011PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250625(21)OMW302500013PT, Manufacturing Lot/Serial Number OMW302500013PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250417(21)OMW302500008PT, Manufacturing Lot/Serial Number OMW302500008PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250425(21)OMW302500010PT, Manufacturing Lot/Serial Number OMW302500010PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250423(21)OMW302500009PT, Manufacturing Lot/Serial Number OMW302500009PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241202(21)OMW302400004PT, Manufacturing Lot/Serial Number OMW302400004PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250331(21)OMW302500007PT, Manufacturing Lot/Serial Number OMW302500007PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241104(21)OMW302400003PT, Manufacturing Lot/Serial Number OMW302400003PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250210(21)OMW302500003PT, Manufacturing Lot/Serial Number OMW302500003PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250110(21)OMW302500001PT, Manufacturing Lot/Serial Number OMW302500001PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250323(21)OMW302500006PT, Manufacturing Lot/Serial Number OMW302500006PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250306(21)OMW302500004PT, Manufacturing Lot/Serial Number OMW302500004PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)241002(21)OMW302400001PT, Manufacturing Lot/Serial Number OMW302400001PT;
Omni PET Gantry 30cm - WSO: UDI (01)00195278901439(11)250317(21)OMW302500005PT, Manufacturing Lot/Serial Number OMW302500005PT. |
Recalling Firm/
Manufacturer |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
9, Andrey Sakharov
Haifa Israel
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| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer Reason
for Recall | 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). |
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FDA Determined
Cause 2 | Software design |
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| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/24/2025 via letter sent using traceable means. The notice explained the problem with the device, safety issue, and provided recommendations (instructions) for the safe use of the device until the correction can be made.
For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
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| Quantity in Commerce | 364 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
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