Recall Z-0319-2018 ยท LEJ Booth, Sun Tan
ProSun International, LLC
Sundream 12 V tanning bed
| Date | Dec 2, 2017 |
| Status | Terminated |
| Reason | The 30 minute maximum tanning time has been reduced to 20 minutes. |
| Root cause | Other |
| Action | Customers were initially notified of the recall on 03/24/2016 and then again on 10/17/2017. Instructions included to check current inventory for the affected device and complete and return the response card to ProSun who will then supply a set of 12 lower output lamps that are rated at 30 minutes maximum tanning time, provide a new Owner's Manual, and a new Tanning Schedule Label with the new 30 min lamps listed. |
| Quantity | 75 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.