FDA Device recall Z-1176-2019
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX…
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX… by Prosun International, citing proSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1176-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Prosun International |
| Distribution | US |
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
Reason
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Identifiers
| code_info | Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065,…Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII3V0070, UNO32SLII2X0075, UNO32SLII1X0069, UNO32SLII2X0073, UNATF32SLII2X0031, UNATF32SLII2X0030, UNO32SLII2X0084, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0081, UNO32SLII2X0091, UNO32SLII4W0050, UNO32SLII4W0047, UNO32SLII3W0011, UNO32SLII2X0079, UNO32SLII3X0095, UNO32SLII2X0094, UNO32SLII1X0056, UNO32SLII1X0057, UNATF32SLIIX0027, UNO32SLII3X0096 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1176-2019%22
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