Z-1177-2019 Class II Terminated
FDA device recall Z-1177-2019 was initiated by ProSun International, LLC on Dec 10, 2018 and is designated Class II. Reason for recall: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. The recall status is terminated (terminated May 2, 2023). Affected quantity: 250 devices of which 9 are affected.
Recall details
- Product Type
- Devices
- Report Date
- Apr 24, 2019
- Initiation Date
- Dec 10, 2018
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 devices of which 9 are affected
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.
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.
Code information
Serial Numbers: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, UN42HV3C2X0430
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1177-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026