Device recall
Z-1112-2026: GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni…
FDA device recall · Class II · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Key facts
| Recall number (Z-number) | Z-1112-2026 |
|---|---|
| Recall event | 98269 |
| 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… |
| Product code | KPS |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K221932, K241665 |
| FEI number | 3027338963 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database