Recall Z-1177-2019— ProSun International, LLC
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 V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY. 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 recordK-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 V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY
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.