Device recall
Z-1006-2018: ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-1006-2018 |
|---|---|
| Recall event | 79266 |
| Product | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation… |
| Product code | IYE |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2021 |
| 510(k) numbers | K120789 |
| 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