Events

Device Recall Syngo.plaza 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
    70318
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1027-2015
  • 사례 시작날짜
    2015-01-13
  • 사례 출판 날짜
    2015-01-28
  • 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=133015
  • 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
    In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. in case of a system crash (e.G. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.
  • 조치
    Siemens sent a Safety Advisory Notice dated January 13, 2015, to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken. Siemens recommended checking patient data in the event of a system crash and advised customers that a software update is planned for mid-2015 that will resolve the issue. For questions regarding this recall call 610-219-6300.

Device

Device Recall Syngo.plaza
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 10592457, 10863171, 10863173, 10863172; with serial numbers: Serial  100544 100262 100198 100258 200211 100135 100133 100213 100031 100084 100233 100140 200308 100245 100314 100139 100177 100197 100170 100025 100174 100186 100033 100306 100232 100185 100256 100199 100188 100257 100198 100226 100198 100228 100181 100029 100253 100301 100203 100132 100139 100247 100215 100230 100221 100146 100207 100212 100539 100206
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. || Syngo.plaza also supports storage and archiving of DICOM Structured reports. || In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. || Syngo.plaza optionally uses a variety of advanced postprocessing applications
  • 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