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FDA Medical Device Recalls (openFDA)

J&T Health and Wellness LLC: ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

Recall number
Z-2636-2023
Recalling firm
J&T Health and Wellness LLC
Product
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Status
Open, Classified
Initiated
2023-03-31
Posted
2023-09-28
Terminated
not on file
Reason
In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
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
12 units
Distribution
US
Lot, serial or model codes
52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037
510(k) numbers
not on file
PMA numbers
not on file
Product code
LEJ
Firm FEI
1000525872
Firm city
Saint Petersburg
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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