ProSun V3 42 Xlc — Class II medical device recall Z-1177-2019
Terminated recall by ProSun International, LLC, reported 2019-04-24, distributed nationwide. ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which coul
| Recall number | Z-1177-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ProSun International, LLC, Saint Petersburg, FL, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2019-04-16 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2023-05-02 |
| Distributed | Nationwide (US) |
| Serial numbers | UN42HV3C1X0407, UN42HV3C1X0409, UN42HV3C1X0410, UN42HV3C1X0414, UN42HV3C2X0430, UN42HV3C2X0435, UN42HV3C3X0431, UN42HV3C3X0450, UN42R2AHV3C2X0111 |
| Model numbers | 500 |
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 for recall
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1177-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.