Events

Recall of Device Recall Hydrospa Capsules

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybaritic, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52036
  • Event Risk Class
    Class 2
  • Event Number
    Z-1602-2009
  • Event Initiated Date
    2007-06-22
  • Event Date Posted
    2009-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81946
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cabinet, moist steam - Product Code IMB
  • Reason
    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.
  • 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.

Device

Device Recall Hydrospa Capsules
  • Model / Serial
    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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Sybaritic, Inc

Manufacturer

Sybaritic, Inc
  • Manufacturer Address
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA