Recall Z-1176-2019— ProSun International, LLC

Name: FDA recall Z-1176-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Class II · Terminated

Class II FDA medical device recall by ProSun International, LLC, initiated 2018-12-10, terminated 2023-05-02. It names one FDA 510(k) clearance: K181455. Product: ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin. Reason: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output..

Recalling firm: ProSun International, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Terminated: 2023-05-02
Firm location: Saint Petersburg, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K181455 — ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC·cleared 2018-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin

Reason for recall

ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.

Data sourced from openFDA. This site is unofficial and independent of the FDA.