Device Recall Sundream 12 V tanning bed

  • Model / Serial
    Model No. 12V, Serial No. SUN12VH1R0006, SUN12VH1R0005, SUN12VH1R0001, SUN12VH1R0004, SUN12VH1R0002, SUN12VH1R0003, SUN12VH1R0007, SUN12VH1R1001, SUN12VH1R0011, SUN12VH1R0012, SUN12VH1R0013, SUN12VH1R0009, SUN12VH1R0010, SUN12VH1R0016, SUN12VH1R0015, SUN12VH1R0017, SUN12VH1R0018, SUN12VH1R0022, SUN12VH1R0021, SUN12VH1R0019, SUN12VH1R0020, SUN12VH1R0023, SUN12VH1R0024, SUN12VH1R0026, SUN12VH1R0027, SUN12VH1R0025, SUN12VH1R0028, SUN12VH1R0033, SUN12VH1R0036, SUN12VH1R0039, SUN12VH1R0041, SUN12VH1R0042, SUN12VH1R0047, SUN12VH1R0043, SUN12VH1R0045, SUN12VH2R0032, SUN12VH1R0040, SUN12VH1R0031, SUN12VH1R0044, SUN12VH1R0050, SUN12VH1R0049, SUN12VH1R0048, SUN12VH1R0055, SUN12VH1R0056, SUN12VH1R0054, SUN12VH1R0057, SUN12VH1S0060, SUN12VH1S0059, SUN12VH1S0058, SUN12VH1R0052, SUN12VH1S0061, SUN12VH1S0062, SUN12VH1R0051, SUN12VH4R0053, SUN12VH1S0063, SUN12VH1S0066, SUN12VH1S0064, SUN12VH1S0065, SUN12VH1S0071, SUN12VH1S0070, SUN12VH1S0068, SUN12VH1S0073, SUN12VH1R0072, SUN12VH1S0075, SUN12VH1S0067, SUN12VH1S0076, SUN12VH1S0069, SUN12VH1S0074, SUN12VH1S0077, SUN12VH1S0079, SUN12VH2S0080, SUN12VH1S0086, SUN12VH2S0081, SUN12VH1R0087, SUN12VH1R0088
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI
  • Product Description
    Sundream 12 V tanning bed
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ProSun International, LLC, 2442 23rd St N, Saint Petersburg FL 33713-4018
  • Manufacturer Parent Company (2017)
  • Source
    USFDA