Device recall
Z-1176-2019: ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as…
FDA device recall · Class II · ProSun International, LLC
Key facts
| Recall number (Z-number) | Z-1176-2019 |
|---|---|
| Recall event | 82346 |
| Product | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin |
| 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