Events

Device Recall Picture archiving and communications 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
    73274
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0826-2016
  • 사례 시작날짜
    2016-01-29
  • 사례 출판 날짜
    2016-02-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143694
  • 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
    Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. in rare situations, echo trend graphs may mix data from multiple patients.
  • 조치
    The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: anastasia.sokolova@siemens.com.

Device

Device Recall Picture archiving and communications system
  • 모델명 / 제조번호(시리얼번호)
    For model #10091673
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
  • 제품 설명
    software for Syngo Dynamics || a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
  • 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