Recall Z-1176-2019 ยท LEJ Booth, Sun Tan
ProSun International, LLC
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
| Date | Dec 10, 2018 |
| Status | Terminated |
| Reason | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. |
| Root cause | Employee error |
| Action | ProSun initially notified customers on about 12/10/2018 via "URGENT: POTENTIAL UV EXPOSURE DISCREPANCY" letter. Instructions included to contact ProSun Customer Service at 727-825-0400 Ext 243 or 224 or by email at jenniferh@prosun.com to coordinate receipt of a UV meter to verify UV output. Once received, customers should take the requested UV readings, fill out the form accompanying the UV meter, and return the UV meter with signed form via the enclosed return label. If there are any out-of-specification readings present, ProSun will contact that customer with a solution. Another custo |
| Quantity | 177 devices of which 31 are affected |
| Distribution | US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181455 | ProSun sunlamp products, Luxura sunlamp products Prosun International, LLC, Sep 10, 2018 |