Sybaritic, Inc: DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above.

Recall number

Z-1604-2009

Recalling firm

Sybaritic, Inc

Product

DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above.

Status

Terminated

Initiated

2007-06-22

Posted

2009-07-13

Terminated

2012-07-05

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.

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

86

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.

Lot, serial or model codes

Part E30008 SERIAL NUMBERS:  G4061142236, G4060942128, G4061052135, G4061042136, G4070142436, G4070452585, G4070252464, G4061242317, G406124307, G406124311, G4061142281, G4070242474, G4070242486, G4070342498, G4070352528, G4061142257, G4061152258, G4061152273, G4070152376, G4070252458, G407044578, G4070342548, G4060842048, G4060852049, G4061152294, G4061252303, G4061252310, G4070242461, G4060952067, G40701424121, G4070152381, G4070152387, G4070342521, G4070352544, G4070552656, G4070552644, G406055898, G4060942068, G4061042145, G4061042214, G4061052149, G4061142244, G4061242326, G4061142299, G4070342506, G4070442577, G4060852053, G4060942074, G4061142259, G4061152228, G4061152240, G4061155248, G4070142363, G4070152400, G4070152408, G4070152437, G4070252463, G4070252473, G4070342517, G4070352495, G4070342529, G4060852019, G4061042186, G4061052212, G4061142224, G4061152220, G4070242448, G4070252442, G4070252484, G4070252487, G4070342491, G4070352505, G4070352509 and G4070352516; and  Part E30008-01 SERIAL NUMBERS:  G406052055, G4061252322, G4060852052, G4070142352, G4061052190, G4061042206, G4061242342, G4061042156, G4061052173, G4061052201, G4061252318, G4060852056 and G4060842058.

510(k) numbers

K003916

PMA numbers

not on file

Product code

IMB

Firm FEI

2131125

Firm city

Bloomington

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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