ClearanceBrief
Recall Z-2636-2023 ยท LEJ Booth, Sun Tan

J&T Health and Wellness LLC

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

DateSep 28, 2023 (initiated Mar 31, 2023)
StatusOpen, Classified
ReasonIn some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
Root causeOther
ActionProSun 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.
Quantity12 units
DistributionUS
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.