Medical device recalls Moderate risk

ProSun International, LLC recalls ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W)…

Recall date
December 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1177-2019
FDA classification
Class II
Brand / firm
ProSun International, LLC
Sold / distributed
US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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