Device 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
Z-1177-2019
Product summary
- Event
- Event 82346
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 devices of which 9 are affected
- Official record key
device-enforcement:Z-1177-2019
Official wording
Reason: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Code information: Serial Numbers: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, UN42HV3C2X0430
Distribution pattern: US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
Derived failure modes
-
Unknown
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.