Events

Device Recall ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transducer 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
    52928
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1961-2011
  • 사례 시작날짜
    2009-03-21
  • 사례 출판 날짜
    2011-04-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84291
  • 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, imaging, pulsed echo, ultrasonic - Product Code ITX
  • 원인
    Overheating. a software bug may cause the transducer to overheat when used with certain transducer models. the transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.
  • 조치
    The firm, SIEMENS, sent a "Customer Safety Advisory Notification" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and /or exam type. In addition, the customers were instructed to pass this notice on to all those within their organization who need to be aware of this issue until the corrective action is completed. SIEMENS will release a software update that will correct the issue. The customers local service engineer will install the updates on their system as soon as it becomes available. Should you have any questions regarding this notification, you may contact your local service support person and/or call (650) 969-9112.

Device

Device Recall ACUSON Sequoia ultra sound systems with Auxiliary 2 MHz Continuous Wve (CW) transd...
  • 모델명 / 제조번호(시리얼번호)
    ACUSON Sequoia serial numbers 50026,  50030,  50042,  50043,  50057,  50087,  50108,  50116,  50172,  50202,  50216,  50243,  50252,  50271,  50279,  50295,  50342,  50355,  50368,  50374,  50418,  50425,  50448,  50493,  50497,  50560,  50561,  50604,  50651,  50676,  50680,  50728,  50777,  50788,  50794,  50796,  50806,  50852,  50855,  50893,  50898,  50920,  50938,  50959,  50964,  51020,  51046,  51055,  51087,  51128,  51185,  51213,  51215,  51229,  51243,  51270,  51278,  51290,  51311,  51332,  51350,  51354,  51367,  51389,  51414,  51433,  51446,  51496,  51498,  51514,  51516,  51523,  51524,  51604,  51636,  51639,  51643,  51652,  51740,  51742,  51747,  51757,  51766,  51781,  51792,  51796,  51800,  51811,  51830,  51844,  51846,  51859,  51897,  51899,  51910,  51920,  51926,  51949,  51955,  51971,  51975,  51979,  51980,  51987,  52003,  52006,  52012,  52023,  52040,  52041,  52047,  52059,  52065,  52075,  52087,  52089,  52101,  52111,  52133,  52136,  52143, 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. || The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA