GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend P
FDA device recall Z-1112-2026 · posted 2026-01-16 · Open, Classified
Recall details
- Recalling firm
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- 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).
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- KPS
- Quantity affected
- 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, Ital
- Date initiated
- 2025-12-24
- Date posted
- 2026-01-16
- Location
- Haifa, Israel
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Omni Legend (K241665) | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 |
| Omni Legend (K221932) | GE Healthcare | 2022-09-02 |