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.
데이터 추가 비고
Cabinet, moist steam - Product Code IMB
원인
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.
조치
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.
PART E30006-02 SERIAL NUMBERS: G1061142263, G1061142291, G1061242316, G1061252324, G1070142367, G1061142263, G1061142291, G1061242316, G1061252324 and G1070142367.
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.
제품 설명
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.