FDA Enforcement Class II Ongoing

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

Recall: Z-2636-2023 · Reported October 4, 2023

Enforcement

Recall Number: Z-2636-2023
Event ID: 92217
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: J&T Health and Wellness LLC
Voluntary / Mandated: N/A
Initial Notification: N/A
Report Date: October 4, 2023
Initiation Date: March 31, 2023
Classification Date: September 28, 2023
Address: 2442 23rd St N, N/A, Saint Petersburg, FL, 33713-4018, United States

Reason

In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.

Code Info

52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037

Distribution

Quantity

12 units