Events

Device Recall Hydrospa Capsules 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sybaritic, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52036
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1602-2009
  • 사례 시작날짜
    2007-06-22
  • 사례 출판 날짜
    2009-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81946
  • 비고 / 경고
    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.

Device

Device Recall Hydrospa Capsules
  • 모델명 / 제조번호(시리얼번호)
    PART E30006 SERIAL NUMBERS: G1070442568, G1070452567, G1060942061, G1061252308, G106064921, G106065928, G10606891, G1061142252, G1061152287, G1061152288, G1061242302, G1070352519, G1061142238, G1061142247, G1061142270, G1061152265, G1061252301, G1061252306, G1070342543, G1060942112, G1061142292, G1061152267, G1070142402, G1070242450, G1070252451, G1070342515, G1070342524, G1070342527, G1070352537, G1070342554, G1070352562, G1070442582, G1070452591, G106075989, G1061042162, G1061042189, G1061052180, G1061052183, G1061052185, G1061052193, G1070542653, G106125312, G1060852039, G1061142239, G1061152237, G1061152251, G1070342508, G1070342511, G1070352514, G1070352555, G1070452580, G1070452586, G1040452600, G106034717, G106054836, G106055876, G106055877, G106055881, G106065924, G106074984, G106074990, G106075988, G106075992, G1060842008, G1060842010, G1060842015, G1060842041, G1060852012, G1060852051, G1060942072, G1060942111, G1060942116, G1060952064, G1060952065, G1060952087, G1060952117, G1060952122, G1061042134, G1061042179, G1061042184, G1061042187, G1061042191, G1061042208, G1061052132, G1061052133, G1061052138, G1061052142, G1061052143, G1061052147, G1061052154, G1061052163, G1061052188, G1061052194, G1061052207, G1061052215, G1061142218, G1061142246, G1061142262, G1061142264, G1061142276, G1061152222, G1061152233, G1061152241, G1061152242, G1061152253, G1061152254, G1061152256, G1061152272, G1061152274, G1061152297, G1061152298, G1061242300, G1061242305, G1061242314, G1061242315, G1061252319, G1061252320, G1070142374, G1070142375, G1070142377, G1070142397, G1070142403, G1070142410, G1070142413, G1070142415, G1070142419, G1070142427, G1070152360, G1070152361, G1070152368, G1070152388, G1070152418, G1070152420, G1070152424, G1070152425, G1070152426, G1070152428, G1070242452, G1070242470, G1070242480, G1070252443, G1070252449, G1070252453, G1070252478, G1070252479, G1070252485, G1070342494, G1070342499, G1070342510, G1070342531, G1070342535, G1070342539, G1070342541, G1070342559, G1070342561, G1070352489, G1070352496, G1070352497, G1070352500, G1070352504, G1070352530, G1070352538, G1070352546, G1070352560, G1070442565, G1070442569, G1070442597, G1070452563, G1070452564, G1070452566, G1070452579, G1070452583, G1070452594, G1070542654, G1060952107, G1070142398, G1070152401, G1070552671, G1070552684, G106074991, G1061042181, G1061042198, G1061052209, G1061052210, G1061052216, G1061142217, G1061142226, G1061142231, G1061142243, G1061142245, G1061152221, G1061152229, G1061152230, G1061152234, G1070142423, G1070242475, G1070342503, G1070342525, G1070352507, G1070352520, G1070352522, G1070352523, G1070352526, G1070352534, G106044763, G106045769, G106054827, G106054844, G106054848, G106054878, G106055834, G106055840, G106055841, G106055881, G106054875, G106054896, G106055893, G106055894, G106054882, G106064923, G106064927, G106065933, G406055869 and G106054870; and  PART E30006-01 SERIAL NUMBERS:  G1060852047, G1061142255, G1061152260, G1061152261, G1061152271, G1061152275, G1060852059, G1060842045, G1060852034, G1061242321, G1061252313, G106852043 and G1060852009.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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 Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can sit on top of. || Part #E30006 - Spa Jet 2G; 220V,50/60Hz. 15A. This is the Spa Jet product without the 2 optional pedestals which the unit can sit on top of.
  • Manufacturer
    Sybaritic, Inc

Manufacturer

Sybaritic, Inc
  • 제조사 주소
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA