Device recall
Z-1155-2013: RoboCouch Patient Positioning System Product Usage: is intended for use in the…
FDA device recall · Class II · Accuray Incorporated
Key facts
| Recall number (Z-number) | Z-1155-2013 |
|---|---|
| Recall event | 64809 |
| Product | RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. |
| Product code | JAI |
| Recalling firm | Accuray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2013 |
| 510(k) numbers | K042146 |
| FEI number | 1000123585 |
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