Device recall
Z-1990-2015: The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems…
FDA device recall · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-1990-2015 |
|---|---|
| Recall event | 71351 |
| Product | The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis. |
| Product code | FSY |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2017 |
| 510(k) numbers | K040735, K070442, K130513 |
| FEI number | 3008355164 |
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