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Z-1602-2009

DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product...

Sybaritic, Inc. / initiated 2007-06-22 / Terminated / root cause: design
FDA source (opens on fda.gov)

Sybaritic, Inc began a recall of DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can... on . The reason FDA records is "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)...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1602-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sybaritic, Inc.
Product
DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can sit on top of. Part #E30006 - Spa Jet 2G; 220V,50/60Hz. 15A. This is the Spa Jet product without the 2 optional pedestals which the unit can sit on top of.
Product code
IMB Cabinet, Moist Steam
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.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
238 units
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.
Product codes and lots
PART E30006 SERIAL NUMBERS: G1070442568, G1070452567, G1060942061, G1061252308, G106064921, G106065928, G10606891, G1061142252, G1061152287, G1061152288, G1061242302, G1070352519, G1061142238, G1061142247, G1061142270, G1061152265, G1061252301, G1061252306, G1070342543, G1060942112, G1061142292, G1061152267, G1070142402, G1070242450, G1070252451, G1070342515, G1070342524, G1070342527, G1070352537, G1070342554, G1070352562, G1070442582, G1070452591, G106075989, G1061042162, G1061042189, G1061052180, G1061052183, G1061052185, G1061052193, G1070542653, G106125312, G1060852039, G1061142239, G1061152237, G1061152251, G1070342508, G1070342511, G1070352514, G1070352555, G1070452580, G1070452586, G1040452600, G106034717, G106054836, G106055876, G106055877, G106055881, G106065924, G106074984, G106074990, G106075988, G106075992, G1060842008, G1060842010, G1060842015, G1060842041, G1060852012, G1060852051, G1060942072, G1060942111, G1060942116, G1060952064, G1060952065, G1060952087, G1060952117, G1060952122, G1061042134, G1061042179, G1061042184, G1061042187, G1061042191, G1061042208, G1061052132, G1061052133, G1061052138, G1061052142, G1061052143, G1061052147, G1061052154, G1061052163, G1061052188, G1061052194, G1061052207, G1061052215, G1061142218, G1061142246, G1061142262, G1061142264, G1061142276, G1061152222, G1061152233, G1061152241, G1061152242, G1061152253, G1061152254, G1061152256, G1061152272, G1061152274, G1061152297, G1061152298, G1061242300, G1061242305, G1061242314, G1061242315, G1061252319, G1061252320, G1070142374, G1070142375, G1070142377, G1070142397, G1070142403, G1070142410, G1070142413, G1070142415, G1070142419, G1070142427, G1070152360, G1070152361, G1070152368, G1070152388, G1070152418, G1070152420, G1070152424, G1070152425, G1070152426, G1070152428, G1070242452, G1070242470, G1070242480, G1070252443, G1070252449, G1070252453, G1070252478, G1070252479, G1070252485, G1070342494, G1070342499, G1070342510, G1070342531, G1070342535, G1070342539, G1070342541, G1070342559, G1070342561, G1070352489, G1070352496, G1070352497, G1070352500, G1070352504, G1070352530, G1070352538, G1070352546, G1070352560, G1070442565, G1070442569, G1070442597, G1070452563, G1070452564, G1070452566, G1070452579, G1070452583, G1070452594, G1070542654, G1060952107, G1070142398, G1070152401, G1070552671, G1070552684, G106074991, G1061042181, G1061042198, G1061052209, G1061052210, G1061052216, G1061142217, G1061142226, G1061142231, G1061142243, G1061142245, G1061152221, G1061152229, G1061152230, G1061152234, G1070142423, G1070242475, G1070342503, G1070342525, G1070352507, G1070352520, G1070352522, G1070352523, G1070352526, G1070352534, G106044763, G106045769, G106054827, G106054844, G106054848, G106054878, G106055834, G106055840, G106055841, G106055881, G106054875, G106054896, G106055893, G106055894, G106054882, G106064923, G106064927, G106065933, G406055869 and G106054870; and  PART E30006-01 SERIAL NUMBERS:  G1060852047, G1061142255, G1061152260, G1061152261, G1061152271, G1061152275, G1060852059, G1060842045, G1060852034, G1061242321, G1061252313, G106852043 and G1060852009.