Device recall
Z-1544-2009: BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-1544-2009 |
|---|---|
| Recall event | 51484 |
| Product | BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access… |
| Product code | IYE |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2010 |
| 510(k) numbers | K970586 |
| 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