Recall Z-1177-2019 ยท LEJ Booth, Sun Tan
ProSun International, LLC
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
| 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 | 250 devices of which 9 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 |