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-1603-2009
  • 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=81947
  • 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 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.
  • 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 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.
  • Manufacturer
    Sybaritic, Inc

Manufacturer

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