ProSun International, LLC: Medical Device Recall in 2019 - (Recall #: Z-1177-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 10, 2018

Date Posted: April 24, 2019

Recall Number: Z-1177-2019

Event ID: 82346

Reason for Recall:

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

Status: Terminated

Product Quantity: 250 devices of which 9 are affected

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.

Voluntary or Mandated:

Voluntary: Firm initiated