FDA recall Z-0319-2018

ProSun International, LLC · Class II · device

Product

Sundream 12 V tanning bed

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-12-02
Report date
2018-01-17
Termination date
2026-02-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Petersburg, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0319-2018