Agency classClass IIOur severity:High FDA (Devices)·Z-1177-2019·Announced 2019-04-24

ProSun V3 42 Tanning Beds Recalled for Potential High UV Output

ProSun International is recalling nine specific tanning beds due to quality control documentation discrepancies that could result in high UV output.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (high UV output) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

ProSun International, LLC is recalling nine specific units of the ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. The affected devices are distributed nationwide in the United States to the states of California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee, Texas, and Wisconsin.

The recall was initiated because the company discovered discrepancies in their Quality Control Checklist documentation. These documentation issues could result in the tanning beds producing high UV output. The source text does not report any illnesses or injuries associated with these devices.

Consumers who own one of the nine affected serial numbers should stop using the device and contact ProSun International, LLC for further instructions. The specific serial numbers for the affected units are: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, and UN42HV3C2X0430.

The recalled product

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…
Manufacturer: ProSun International, LLC
Category: Consumer Product — Tanning Equipment
Hazard: uv-exposure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Serial Numbers: UN42R2AHV3C2X0111
UN42HV3C2X0435
UN42HV3C3X0450
UN42HV3C1X0414
UN42HV3C1X0407
UN42HV3C1X0410
UN42HV3C1X0409
UN42HV3C3X0431
UN42HV3C2X0430

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ProSun International, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · ProSun International, LLC

See all →

High
ProSun Onyx 32 Sli Intensive Tanning Bed Recalled for UV Output Discrepancies
FDA (Devices) · 2019-04-24
Moderate
ProSun Sundream 12 V tanning bed recalled for reduced maximum tanning time
FDA (Devices) · 2018-01-17

Same hazard · uv exposure