Device recall
Z-0234-2018: Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
FDA device recall · Class II · Elekta Inc
Key facts
| Recall number (Z-number) | Z-0234-2018 |
|---|---|
| Recall event | 78665 |
| Product | Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. |
| Product code | MUJ |
| Recalling firm | Elekta Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K080601 |
| FEI number | 1937649 |
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