Device recall
Z-1807-2014: iGUIDE System Product Usage: The intended use of the device is the control of…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1807-2014 |
|---|---|
| Recall event | 68430 |
| Product | iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. |
| Product code | IYE |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2017 |
| 510(k) numbers | K072079 |
| FEI number | 1037831 |
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