Events

Device Recall SOMATOM Sensation CT Systems 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
    34995
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0797-06
  • 사례 시작날짜
    2006-03-17
  • 사례 출판 날짜
    2006-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45095
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • 원인
    Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ecg-gated scan protocols in the ct2006a and ct2006g software of their somatom sensation ct systems.
  • 조치
    Firm has issued an advisory letter (3/28/2006) to affected customers per Update Instructions CT008/06/S. This letter informs customers about the potential problem and provides instructions to avoid this issue. A Siemens Service Engineer will visit affected sites to hand-deliver this letter and to delete any affected scan protocols, which can then be replaced with default protocols or with new customized protocols.

Device

Device Recall SOMATOM Sensation CT Systems
  • 모델명 / 제조번호(시리얼번호)
    Sensation 10 model number 7543015, Sensation 16 model number 7393114, Sensation 64 model number 8377520, and Sensation Open model number 8872017. Software versions CT2006A and CT2006G.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. Product was distributed to medical facilities in AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL IN, KS, KY, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TX, UT and WI.
  • 제품 설명
    SOMATOM Sensation CT Systems
  • 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 19355-1406
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA