Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2636-2023Class II

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

J&T Health and Wellness LLC / initiated 2023-03-31 / Open, Classified

J&T Health and Wellness LLC began a recall of ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device on . FDA classified it as Class II and gives the reason as "In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2636-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
J&T Health and Wellness LLC
Product
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Product code
LEJ Booth, Sun Tan
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 root 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
Product codes and lots
52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2636-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2636-2023Class IIOngoingN/A