Device recall
Z-1308-2022: VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF…
FDA device recall · Class II · Getinge Usa Sales Inc
Key facts
| Recall number (Z-number) | Z-1308-2022 |
|---|---|
| Recall event | 90305 |
| Product | VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF… |
| Product code | FSY |
| Recalling firm | Getinge Usa Sales Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K130513 |
| FEI number | 3013876692 |
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