Device recall
Z-1177-2019: ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the…
FDA device recall · Class II · ProSun International, LLC
Key facts
| Recall number (Z-number) | Z-1177-2019 |
|---|---|
| Recall event | 82346 |
| Product | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY |
| Product code | LEJ |
| Recalling firm | ProSun International, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2023 |
| 510(k) numbers | K181455 |
| FEI number | 1000525872 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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