Events

Device Recall Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    58885
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2786-2011
  • 사례 시작날짜
    2011-03-31
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100474
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • 원인
    Firm has discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation.
  • 조치
    Siemens initated their recall of the device on March 31, 2001, by sending a Customer Safety Advisory Notice/Letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that detectors will be installed in appropriate locations on the system, which will switch off the system's power electronics in the event of a malfunction in the power supply of the gradient coils, preventing damage to the system and its environment.

Device

Device Recall Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System
  • 모델명 / 제조번호(시리얼번호)
    Model numbers 4760265, 7104594, 7104719, 7104735, 7106425 and 7106557.  Serial numbers 21604, 21235, 14151, 13314, 14312, 22499, 13438, 22301, 22211, 22311, 14247, 22127, 14436, 14228, 22518, 22165, 22200, 14306, 14426, 13044, 14138, 22438, 14023, 21204, 22344, 14196, 22195, 22276, 22355, 14424, 14369, 14393, 21279, 22491, 14114, 22309, 14344, 14101, 22386, 22523, 14373, 22609, 22305, 22090, 22561, 14394, 14292, 22580, 22524, 22568, 22573, 14144, 22173, 22270, 22511, 14009, 14087, 14175, 22170, 22604, 22115, 14024, 22114, 14383, 22352, 22121, 14097, 14486, 14155, 14234, 21250, 22587, 14204, 22243, 22408, 14060, 13121, 22621, 14323, 22557, 22250, 22029, 21936, 22356, 22079, 22342, 14405, 14338, 22126, 14379, 14015, 22618, 14360, 22463, 22307, 14237, 14206, 14276, 14278, 22418, 22649, 21928, 22643, 14343, 14188, 14376, 14409, 22153, 22642, 22312, 22084, 14387, 22444, 14448, 14314, 22097, 14429, 14072, 21200, 14390, 14348, 14229, 21608, 22543, 21253, 14341, 13108, 22221, 14488, 14066, 22647, 22193, 13523, 14389, 22610, 22321, 14299, 14484, 22316, 14447, 21108, 22298, 14158, 22591, 14231, 14487, 22623, 14385, 22302, 22196, 14201, 14225, 22169, 14368, 22277, 14252, 14319, 22075, 14328, 14265, 13413, 13345, 22237, 21268, 22629, 14444, 14450, 14431, 21926, 22324, 22225, 22241, 22265, 14076, 22483, 14221, 14220, 14346, 22330, 22108, 22650, 22617, 22403, 22134, 22212, 22047, 21174, 22319, 14148, 22608, 22286, 22357, 13135, 21105, 21155, 21201, 22092, 14363, 22145, 14415, 21142, 22322, 14371, 14417, 14438, 22046, 22534, 22441, 22010, 22080, 22435, 14182, 22021, 14198, 21205, 14219, 14270, 14412, 14437, 22536, 22248, 22471, 22503, 22506, 14119, 22242, 14258, 14474, 14452, 22306, 14357, 21611, 14010, 22616, 21262, 22216, 22171, 21119, 22576, 22174, 22407, 14381, 21186, 22162, 22103, 22228, 14386, 14161, 22605, 22346, 22406, 14443, 22565, 22639, 22105, 14380, 22638, 21189, 14044, 14413, 14186, 22215, 14432, 22582, 14423, 22130, 22497, 22024, 22490, 14105, 21906, 14356, 22164, 22093, 22345, 14321, 22636, 14398, 14355, 22607, 13255, 22189, 22190, 22478, 22400, 22579, 22218, 22273, 14041, 14126, 22073, 22451, 14184, 14256, 14288, 22588, 22091, 14232, 14401, 21171, 13110, 22519, 14043, 22271, 22051, 22261, 14453, 22255, 22031, 22520, 22455, 21289, 21238, 22011, 14137, 22551, 14345, 22129, 22207, 14235, 22063, 21249, 22372, 22083, 22402, 13325, 22358, 22572, 22416, 14449, 14180, 21914, 14193, 22113, 22184, 22569, 22433, 22493, 22172, 22606, 14092, 14272, 14427, 14085, 14399, 22622, 22624, 14038, 22266, 22060, 14223, 21202, 22398, 22461, 22244, 21131, 14035, 13475, 22095, 14322, 14433, 22068, 14115, 13415, 14411, 22036, 22050, 14093, 14142, 14313, 14324, 14211, 14261, 22646, 14349, 22429, 22182, 22574, 22625, 22361, 14460, 14146, 21260, 21612, 14160, 22118, 21904, 14215, 14013, 14251, 14397, 22071, 14128, 21107, 21264, 14109, 14430, 21239, 21236, 14177, 14055, 14226, 21232, 22401, 13114, 22272, 22530, 14472, 22596, 21138, 21299, 14189, 14230, 14245, 22464, 21215, 22282, 14036, 14048, 22339, 22602, 22535, 22510, 14334, 22074, 21251, 14340, 22648, 14238, 22615, 14120, 22104, 14434, 22030, 21165, 14362, 22175, 22550, 21248, 14051.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and Puerto Rico.
  • 제품 설명
    Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System || Nuclear magnetic resonance imaging system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA