Recall Z-2636-2023— J&T Health and Wellness LLC
Class II · Ongoing
Class II FDA medical device recall by J&T Health and Wellness LLC, initiated 2023-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device. Reason: In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit..
- Recalling firm
- J&T Health and Wellness LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-31
- Firm location
- Saint Petersburg, FL, United States
Product description
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Reason for recall
In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.