Z-1176-2019 Class II Terminated
FDA device recall Z-1176-2019 was initiated by ProSun International, LLC on December 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: 177 devices of which 31 are affected.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- December 10, 2018
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177 devices of which 31 are affected
Product Description
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
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: 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