Device recall
Z-0978-2014: DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0978-2014 |
|---|---|
| Recall event | 65309 |
| Product | DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible. |
| Product code | IXI |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2015 |
| 510(k) numbers | K001163 |
| FEI number | 1037831 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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