Device recall
Z-1546-2009: BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-1546-2009 |
|---|---|
| Recall event | 51484 |
| Product | BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing… |
| Product code | IYE |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2010 |
| 510(k) numbers | K020860 |
| 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