Device recall
Z-0957-2015: iPlan RT is a radiation treatment planning system that is intended for use in…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0957-2015 |
|---|---|
| Recall event | 69960 |
| Product | iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. |
| Product code | MUJ |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2018 |
| 510(k) numbers | K053584, K080888, K103246 |
| FEI number | 3002619595 |
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