Recall Z-1176-2019
ProSun International, LLC · initiated December 10, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
Codes / lots: Serial Numbers: UNO32SLII4W0048, UNO32SLII1X0052, UNO32SLII1X0063, UNATF32SLII1X0028, UNO32SLII1X0064, UNO32SLII1X0065, UNO32SLII1X0067, UNO32SLII1X0068, UNO32SLII2X0071, UNO32SLII2X0072, UNO32SLII3V0070, UNO32SLII2X0075, UNO32SLII1X0069, UNO32SLII2X0073, UNATF32SLII2X0031, UNATF32SLII2X0030, UNO32SLII2X0084, UNO32SLII2X0082, UNO32SLII2X0083, UNO32SLII2X0081, UNO32SLII2X0091, UNO32SLII4W0050, UNO32SLII4W0047, UNO32SLII3W0011, UNO32SLII2X0079, UNO32SLII3X0095, UNO32SLII2X0094, UNO32SLII1X0056, UNO32SLII1X0057, UNATF32SLIIX0027, UNO32SLII3X0096
Reason for recall
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
FDA-determined cause: Employee error
Action taken
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 jenniferh@prosun.com 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.
Details
- Recall number
- Z-1176-2019
- Initiated
- December 10, 2018
- Terminated
- May 2, 2023
- Product code
- LEJ – Booth, Sun Tan
- Quantity
- 177 devices of which 31 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.
- Recalling firm
- ProSun International, LLC, Saint Petersburg, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1177-2019 Class II | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following:…ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which… | 12/10/2018Terminated |