Device recall
Z-0001-2018: Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the…
FDA device recall · Class II · Carl Zeiss Meditec AG
Key facts
| Recall number (Z-number) | Z-0001-2018 |
|---|---|
| Recall event | 78082 |
| Product | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments |
| Product code | JAD |
| Recalling firm | Carl Zeiss Meditec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 24, 2018 |
| 510(k) numbers | K051055, K090584, K110590 |
| FEI number | 3003481798 |
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