Device recall
Z-1937-2018: VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June…
FDA device recall · Class II · Maquet SAS
Key facts
| Recall number (Z-number) | Z-1937-2018 |
|---|---|
| Recall event | 79898 |
| Product | VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL… |
| Product code | FTD |
| Recalling firm | Maquet SAS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2020 |
| 510(k) numbers | K130513 |
| FEI number | 3002465150 |
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