Device recall
Z-1349-2018: VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM…
FDA device recall · Class II · GETINGE US SALES LLC
Key facts
| Recall number (Z-number) | Z-1349-2018 |
|---|---|
| Recall event | 79583 |
| Product | VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be… |
| Product code | FSY |
| Recalling firm | GETINGE US SALES LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2021 |
| 510(k) numbers | K130513 |
| FEI number | 3012092534 |
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