Z-1177-2019Class II

ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH...

Name: Z-1177-2019 ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH...
Creator: ProSun International, LLC
Published: 2018-12-10
License: https://open.fda.gov/license/

J&T Health and Wellness LLC / initiated 2018-12-10 / Terminated / root cause: manufacturing process

FDA source

ProSun International, LLC began a recall of 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... on 2018-12-10. FDA classified it as Class II and gives the reason as "ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1177-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Posted: 2019-04-16
Terminated: 2023-05-02
Recalling firm: J&T Health and Wellness LLC
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
Product code: LEJ Booth, Sun Tan
Reason for recall: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: ProSun initially notified customers on about 12/10/2018 via "URGENT: POTENTIAL UV EXPOSURE DISCREPANCY" letter. Instructions included to contact ProSun Customer Service at 727-825-0400 Ext 243 or 224 or by email at [email protected] to coordinate receipt of a UV meter to verify UV output. Once received, customers should take the requested UV readings, fill out the form accompanying the UV meter, and return the UV meter with signed form via the enclosed return label. If there are any out-of-specification readings present, ProSun will contact that customer with a solution. Another customer notification was sent to customers on about 3/11/19 via "URGENT: Urgent Recall Notice" letter. Instructions included were the same as the 12/10/18 letter. Customers who were initially contacted via telephone call received a follow up letter with the same instructions. If you have any questions, Contact ProSun Customer Service at 727-825-0400 Ext 224.
Quantity in commerce: 250 devices of which 9 are affected
Distribution: US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
Product codes and lots: Serial Numbers: UN42R2AHV3C2X0111, UN42HV3C2X0435, UN42HV3C3X0450, UN42HV3C1X0414, UN42HV3C1X0407, UN42HV3C1X0410, UN42HV3C1X0409, UN42HV3C3X0431, UN42HV3C2X0430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1177-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1176-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-16
Z-1177-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-16

Product code LEJ

K181455Class IIProSun sunlamp products, Luxura sunlamp productsProsun International, LLC / cleared 2018-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)