Device recall
Z-1164-2026: Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1164-2026 |
|---|---|
| Recall event | 97958 |
| Product | Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K210500 |
| FEI number | 1037831 |
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