Device recall
Z-1513-2014: ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-1513-2014 |
|---|---|
| Recall event | 67719 |
| Product | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0… |
| Product code | IYE |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2017 |
| 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