Events

Siemens syngo WorkFlow SLR, Radiological Information 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
    64737
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1105-2013
  • 사례 시작날짜
    2012-10-05
  • 사례 출판 날짜
    2013-04-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116883
  • 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
    Under certain conditions, when using the search functionality, the potential exists for the wrong patient's interactive documents to display when viewing a signed report in the single patient view. this can occur when the interactive document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. the notes viewer will.
  • 조치
    Siemens Medical sent a Customer Safety Advisory Notice letter dated October 5, 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. There will be a Hot Fix available. If you have any further questions please contact Siemens Customer Product Support at (1-888) 767-8326.

Device

Siemens syngo WorkFlow SLR, Radiological Information System
  • 모델명 / 제조번호(시리얼번호)
    Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries of Canada and Australia.
  • 제품 설명
    Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 || The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS
  • 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