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U.S. Department of Health and Human Services

Class 2 Device Recall Tanning bed

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 Class 2 Device Recall Tanning bedsee related information
Date Initiated by FirmDecember 10, 2018
Create DateApril 16, 2019
Recall Status1 Terminated 3 on May 02, 2023
Recall NumberZ-1177-2019
Recall Event ID 82346
510(K)NumberK181455 
Product Classification Booth, sun tan - Product Code LEJ
ProductProSun 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
Code Information Serial Numbers: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, UN42HV3C2X0430 
FEI Number 1000525872
Recalling Firm/
Manufacturer		 ProSun International, LLC
2442 23rd St N
Saint Petersburg FL 33713-4018
For Additional Information ContactJennifer Henkemans
727-825-0400
Manufacturer Reason
for Recall		ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
FDA Determined
Cause 2		Employee error
ActionProSun initially notified customers on about 12/10/2018 via "URGENT: POTENTIAL UV EXPOSURE DISCREPANCY" letter. Instructions included to contact ProSun Customer Service at 727-825-0400 Ext 243 or 224 or by email at jenniferh@prosun.com to coordinate receipt of a UV meter to verify UV output. Once received, customers should take the requested UV readings, fill out the form accompanying the UV meter, and return the UV meter with signed form via the enclosed return label. If there are any out-of-specification readings present, ProSun will contact that customer with a solution. Another customer notification was sent to customers on about 3/11/19 via "URGENT: Urgent Recall Notice" letter. Instructions included were the same as the 12/10/18 letter. Customers who were initially contacted via telephone call received a follow up letter with the same instructions. If you have any questions, Contact ProSun Customer Service at 727-825-0400 Ext 224.
Quantity in Commerce250 devices of which 9 are affected
DistributionUS Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LEJ
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