Events

Device Recall Syngo XWorkplace 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
    72751
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0597-2016
  • 사례 시작날짜
    2015-11-18
  • 사례 출판 날짜
    2016-01-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142124
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    Potential post-processing software issue when using tabcard "4d" on x-workplace with software version vd10e. a too small measurement in the mprs of a volume when images are acquired with a ct scanner with a tilted gantry. in a 2x2 layout, the 4d tabcard will show an incorrect, too small length measurement. this could result in selecting a device of the wrong size, which then needs to be exchanged.
  • 조치
    Siemens sent an Important Customer Safety Notice dated November 17, 2015. The Notice identified the product, the problem, and the action to be taken by the customer. The potential issue will be remedied with a software update via Update Instructions AX067/15/S. Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers with questions were advised to call 800-888-7436.

Device

Device Recall Syngo XWorkplace
  • 모델명 / 제조번호(시리얼번호)
    Software Version: SW VD-10E
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.
  • 제품 설명
    Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA