Z-1605-2009

DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for...

Name: Z-1605-2009 DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for...
Creator: Sybaritic, Inc
Published: 2007-06-22
License: https://open.fda.gov/license/

Sybaritic, Inc. / initiated 2007-06-22 / Terminated / root cause: design

FDA source

Sybaritic, Inc began a recall of DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor... on 2007-06-22. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1605-2009
Status: Terminated
Initiated: 2007-06-22
Posted: 2009-07-13
Terminated: 2012-07-05
Recalling firm: Sybaritic, Inc.
Product: DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.
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: 10
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 E30006-02 SERIAL NUMBERS: G1061142263, G1061142291, G1061242316, G1061252324, G1070142367, G1061142263, G1061142291, G1061242316, G1061252324 and G1070142367.

Product code IMB

K003916Class IIDermalife Hydrofusion Skin & Body Care SystemScandia Manufacturing , Ltd. / cleared 2002-04-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)