GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Om...
Reason for Recall / Hazard
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).
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Haifa |
| Event id | 98269 |
| Address 1 | 9, Andrey Sakharov |
| Code info | 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)001... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 364 units |
| 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251224 |
| Initial firm notification | Letter |
| Center classification date | 20260116 |
Overview
- Recalling FirmGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.