DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above.
- Company
- Sybaritic, Inc
- Recall Initiated
- June 22, 2007
- Posted
- July 13, 2009
- Terminated
- July 5, 2012
- Recall Number
- Z-1604-2009
- Quantity
- 86
- 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 E30008 SERIAL NUMBERS: G4061142236, G4060942128, G4061052135, G4061042136, G4070142436, G4070452585, G4070252464, G4061242317, G406124307, G406124311, G4061142281, G4070242474, G4070242486, G4070342498, G4070352528, G4061142257, G4061152258, G4061152273, G4070152376, G4070252458, G407044578, G4070342548, G4060842048, G4060852049, G4061152294, G4061252303, G4061252310, G4070242461, G4060952067, G40701424121, G4070152381, G4070152387, G4070342521, G4070352544, G4070552656, G4070552644, G406055898, G4060942068, G4061042145, G4061042214, G4061052149, G4061142244, G4061242326, G4061142299, G4070342506, G4070442577, G4060852053, G4060942074, G4061142259, G4061152228, G4061152240, G4061155248, G4070142363, G4070152400, G4070152408, G4070152437, G4070252463, G4070252473, G4070342517, G4070352495, G4070342529, G4060852019, G4061042186, G4061052212, G4061142224, G4061152220, G4070242448, G4070252442, G4070252484, G4070252487, G4070342491, G4070352505, G4070352509 and G4070352516; and Part E30008-01 SERIAL NUMBERS: G406052055, G4061252322, G4060852052, G4070142352, G4061052190, G4061042206, G4061242342, G4061042156, G4061052173, G4061052201, G4061252318, G4060852056 and G4060842058.
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.