Device recall
Z-0405-2013: INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen…
FDA device recall · Class II · Carl Zeiss Meditec, Inc.
Key facts
| Recall number (Z-number) | Z-0405-2013 |
|---|---|
| Recall event | 63596 |
| Product | INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. |
| Product code | JAD |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2012 |
| 510(k) numbers | K090584 |
| FEI number | 2918630 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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