Events

SYNAPSE PACS LLZ 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fujifilm Medical Systems U.S.A., 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
    75192
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0073-2017
  • 사례 시작날짜
    2016-09-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149629
  • 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
    Image data for a patients image may not be correct.
  • 조치
    The firm, FMSU, sent a "Medical Device Correction" letter dated September 15, 2016 to its customers. The letter describes the product, problem and actions to be taken. The firm will install a patch that corrects the issue (Synapse IPSS v1.3.1.0 Patch).Customers with Version 4.0 may upgrade to version 4.4 (will not require the patch) or upgrade to 4.1, 4.2, or 4.3 and install the patch. FMSU will install the patch on the server remotely if your site uses Active Monitoring. Your notification that the patch was installed will be your service ticket. For sites not using Active Monitoring, FMSU will schedule a time to install the patch on your server. Questions or concerns, contact the FUJIFILM Customer Support Center at 1-888-FUJIMED (1-800-385-4633) Option #1. International callers can access the FUJIFILM Customer Support Center by calling 1-203-602-3580.

Device

SYNAPSE PACS LLZ
  • 모델명 / 제조번호(시리얼번호)
    Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx || Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
  • Manufacturer
    Fujifilm Medical Systems U.S.A., Inc.

Manufacturer

Fujifilm Medical Systems U.S.A., Inc.
  • 제조사 주소
    Fujifilm Medical Systems U.S.A., Inc., 419 West Ave, Stamford CT 06902-6343
  • 제조사 모회사 (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA