Medical device recalls Moderate risk

ProSun International, LLC recalls Sundream 12 V tanning bed

Recall date
December 2, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0319-2018
FDA classification
Class II
Brand / firm
ProSun International, LLC
Sold / distributed
Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI

Why it was recalled

The 30 minute maximum tanning time has been reduced to 20 minutes.

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

What was recalled

Sundream 12 V tanning bed

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