ProSun Luxura Vegaz Model 52X UV Tanning Device Safety Circuit Defect Recall
J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a potential safety circuit defect in a UV tanning device. The hazard represents a risk-of-harm situation where improper device operation could result, though no illnesses or injuries have been reported.
Plain-English summary
J&T Health and Wellness LLC is recalling the ProSun Luxura Vegaz Model 52X ultraviolet (UV) tanning device. The recalled units include model codes 52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, and 52X0037.
The communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit. This defect may prevent the safety circuit from operating properly.
The affected devices have been distributed in the United States. A total of 12 units are involved in this recall.
Consumers who own a ProSun Luxura Vegaz Model 52X should check the model code on their device. If it matches one of the affected codes, stop using the device and contact J&T Health and Wellness LLC for further instructions.
The recalled product
- Product
- ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
- Manufacturer
- J&T Health and Wellness LLC
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 52X0012
- 52X0013
- 52X0014
- 52X0024
- 52X0029
- 52X0030
- 52X0031
- 52X0032
- 52X0033
- 52X0034
- 52X0036
- 52X0037
Distribution
Distribution scope not specified by the agency.
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