Device recall
Z-2251-2009: BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-2251-2009 |
|---|---|
| Recall event | 52988 |
| Product | BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment… |
| Product code | MUJ |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 16, 2011 |
| 510(k) numbers | K002509, K080888, K920879, K994413 |
| 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