Device recall
Z-0116-2022: Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0116-2022 |
|---|---|
| Recall event | 88681 |
| Product | Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2024 |
| 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