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Terminated

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.

FDA Recall Z-1603-2009 · Posted 2009-07-13

Recalling FirmSybaritic, Inc
Recall StatusTerminated
Product CodeIMB
Date Initiated2007-06-22
Date Terminated2012-07-05
Product Quantity29

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003916DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEMScandia Manufacturing , Ltd. · 2002-04-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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