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ProSun International, LLC recalls ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSI

Recalled April 24, 2019 · FDA recall Z-1176-2019 · ProSun International

Hazard
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. · FDA Class II
Units
177 devices of which 31 are affected
Sold at
US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.

Description

ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

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
Manufacturer(s)
ProSun International, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

ProSun International, LLC recalls ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSI | RecallWatchUSA