Device recall
Z-0115-2022: Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143…
FDA device recall · Class II · ELEKTA SOLUTIONS AB
Key facts
| Recall number (Z-number) | Z-0115-2022 |
|---|---|
| Recall event | 88771 |
| Product | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093. |
| Product code | IYE |
| Recalling firm | ELEKTA SOLUTIONS AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2024 |
| 510(k) numbers | K210500 |
| FEI number | 3015232217 |
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