Device recall
Z-0077-2013: Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights…
FDA device recall · Class II · Trumpf Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0077-2013 |
|---|---|
| Recall event | 63255 |
| Product | Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. |
| Product code | FSY |
| Recalling firm | Trumpf Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2014 |
| 510(k) numbers | K011693 |
| FEI number | 3003184737 |
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