Device recall
Z-0484-2014: Helion S Exam Light or H300 The device is intended to locally illuminate an…
FDA device recall · Class II · Trumpf Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0484-2014 |
|---|---|
| Recall event | 66790 |
| Product | Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice. |
| Product code | FSY |
| Recalling firm | Trumpf Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 6, 2017 |
| 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