Device recall
Z-0930-2015: Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0930-2015 |
|---|---|
| Recall event | 69987 |
| Product | Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff. |
| Product code | FST |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2015 |
| 510(k) numbers | K100395 |
| FEI number | 1527821 |
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