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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2636-2023 | Class II | Ongoing | N/A |
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