Device recall
Z-2535-2018: HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-2535-2018 |
|---|---|
| Recall event | 80471 |
| Product | HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy |
| Product code | JAI |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2020 |
| 510(k) numbers | K072898 |
| FEI number | 1037831 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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