Events

Device Recall 4Z1c 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
    53211
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2149-2011
  • 사례 시작날짜
    2009-07-10
  • 사례 출판 날짜
    2011-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84986
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.
  • 조치
    A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.

Device

Device Recall 4Z1c Transducer
  • 모델명 / 제조번호(시리얼번호)
    seial numbers
  • 의료기기 분류등급
    Radiology Devices
  • 유통
    Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.
  • 제품 설명
    4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA. || The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include pediatric echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and intra-operative pediatric abdominal imaging and peripheral vessel imaging.
  • 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