ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Summary
The FDA issued a Class II for ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device by J&T Health and Wellness LLC. Reason: In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit..
Details
Source
Device Recall
External ID
Z-2636-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
Product Description
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Lot/Code Info: 52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037
Quantity Affected: 12 units
Reason for Recall
In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
Distribution
US
Type: N/A
Recall Initiated: 2023-03-31
Company
Saint Petersburg, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (J&T Health and Wellness LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does J&T Health and Wellness LLC have FDA actions?
This is the only FDA action we have on record for J&T Health and Wellness LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2636-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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