DERMALIFE Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G;100V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 100V version which was produced specifically for our Japanese consignee to meet Japan's specialized 100V electrical requirements. Part #E30007-200 is: Spa-Feng Shui 2G;200V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 200V version which was produced specifically for our Japanese consignee to meet Japan's specialized 200V electrical requirements. Part #E30007-01 - Feng Shui 2G; Assay w/Pedestal. This is the Spa Feng Shui product including the 2 optional pedestals which the unit can sit on top of.
- Company
- Sybaritic, Inc
- Recall Initiated
- June 22, 2007
- Posted
- July 13, 2009
- Terminated
- July 5, 2012
- Recall Number
- Z-1603-2009
- Quantity
- 29
- Firm Location
- Bloomington, MN
Reason for Recall
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.
Distribution
Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.
Lot / Code Info
PART E30007 SERIAL NUMBERS: G20601042211, G206035726, G2070352502, G206034722, G206054897, G206064937, G206064948, G206065935, G206075975, G2070142370, G2070152369, G2070152379, G2070542647, G2060742004, G2061152227, G2061152295, G2070242438, G2070242445, G2070242456, G2070252439, G2070252459 and G2070242457; and PART E30007-01 SERIAL NUMBERS: G206074977, G2060952073, G2060942062 and G2060952069; and PART E30007-100 SERIAL NUMBERS: G2070142380 and G2070152372; and PART E30007-200 SERIAL NUMBER: G2070242466.
Root Cause
Device Design
Action Taken
Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered. For further questions, contact Sybaritic, Inc. at 1-800-445-8418.