ProSun International, LLC: Medical Device Recall in 2018 - (Recall #: Z-0319-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Sundream 12 V tanning bed

Product Classification:

Class II

Date Initiated: December 2, 2017

Date Posted: January 17, 2018

Recall Number: Z-0319-2018

Event ID: 78571

Reason for Recall:

The 30 minute maximum tanning time has been reduced to 20 minutes.

Status: Terminated

Product Quantity: 75 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated