Recall Z-1112-2026 ยท KPS System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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 PE
| Date | Jan 16, 2026 (initiated Dec 24, 2025) |
| Status | Completed |
| 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). |
| Root cause | Software design |
| 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. |
| Quantity | 364 units |
| 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, Roma |
| FDA record | Open on fda.gov |