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Recall Observatory FDA recall evidence

Device product

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

Z-2636-2023

March 31, 2023

Class II

Product summary

Firm
J&T Health and Wellness LLC
Event
Event 92217
Status
Ongoing
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2636-2023

Official wording

Reason: In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.

Code information: 52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.