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U.S. Department of Health and Human Services

Class 2 Device Recall Hydrospa Capsules

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 Class 2 Device Recall Hydrospa Capsulessee related information
Date Initiated by FirmJune 22, 2007
Date PostedJuly 13, 2009
Recall Status1 Terminated 3 on July 05, 2012
Recall NumberZ-1605-2009
Recall Event ID 52036
510(K)NumberK003916 
Product Classification Cabinet, moist steam - Product Code IMB
ProductDERMALIFE 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.
Code Information PART E30006-02 SERIAL NUMBERS:  G1061142263, G1061142291, G1061242316, G1061252324, G1070142367, G1061142263, G1061142291, G1061242316, G1061252324 and G1070142367. 
Recalling Firm/
Manufacturer		 Sybaritic, Inc
9220 James Ave S
Bloomington MN 55431-2302
For Additional Information Contact
952-888-8282
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionSybaritic, 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 Commerce10
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IMB
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