Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tanning bed

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Tanning bed see related information
Date Initiated by Firm December 10, 2018
Create Date April 16, 2019
Recall Status1 Terminated 3 on May 02, 2023
Recall Number Z-1177-2019
Recall Event ID 82346
510(K)Number K181455  
Product Classification Booth, sun tan - Product Code LEJ
Product 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
Code Information Serial Numbers: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, UN42HV3C2X0430 
Recalling Firm/
Manufacturer		 ProSun International, LLC
2442 23rd St N
Saint Petersburg FL 33713-4018
For Additional Information Contact Jennifer 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
Action ProSun 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 Commerce 250 devices of which 9 are affected
Distribution US 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 Cycle TPLC 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) Database 510(K)s with Product Code = LEJ and Original Applicant = ProSun International LLC
-
-