Class 2 Device Recall ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

• Date Initiated by Firm: March 31, 2023
• Date Posted: September 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2636-2023
• Recall Event ID: 92217
• Product Classification: Booth, sun tan - Product Code LEJ
• Product: ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
• Code Information: 52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037
• FEI Number: 1000525872
• Recalling Firm/ Manufacturer: J&T Health and Wellness LLC; 2442 23rd St N; Saint Petersburg FL 33713-4018
• For Additional Information Contact: 727-825-0400
• Manufacturer Reason for Recall: In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
• FDA Determined Cause: Other
• Action: ProSun INTERNATIONAL notified their consignees by email on 04/19/2023 a potential safety issue with their tanning beds. The notice explained the issue and requested the consignee cease use until the correction of the device can be conducted.
• Quantity in Commerce: 12 units
• Distribution: US
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.