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Class 2 Device Recall Tanning bed |
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Date Initiated by Firm |
December 10, 2018 |
Create Date |
April 16, 2019 |
Recall Status1 |
Terminated 3 on May 02, 2023 |
Recall Number |
Z-1176-2019 |
Recall Event ID |
82346 |
510(K)Number |
K181455
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Product Classification |
Booth, sun tan - Product Code LEJ
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Product |
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE
Tanning of the skin |
Code Information |
Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII3V0070, UNO32SLII2X0075, UNO32SLII1X0069, UNO32SLII2X0073, UNATF32SLII2X0031, UNATF32SLII2X0030, UNO32SLII2X0084, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0081, UNO32SLII2X0091, UNO32SLII4W0050, UNO32SLII4W0047, UNO32SLII3W0011, UNO32SLII2X0079, UNO32SLII3X0095, UNO32SLII2X0094, UNO32SLII1X0056, UNO32SLII1X0057, UNATF32SLIIX0027, UNO32SLII3X0096 |
Recalling Firm/ Manufacturer |
ProSun International, LLC 2442 23rd St N Saint Petersburg FL 33713-4018
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For Additional Information Contact |
Jennifer Henkemans 727-825-0400
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Manufacturer Reason for Recall |
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
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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 |
177 devices of which 31 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
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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.
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510(K) Database |
510(K)s with Product Code = LEJ and Original Applicant = ProSun International LLC
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