Device Recall Centricity Enterprise Archive 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ge Healthcare It 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
    64761
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2739-2016
  • 사례 시작날짜
    2012-11-16
  • 사례 출판 날짜
    2016-09-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-01-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • 원인
    There is a potential for data loss associated with empty path names resulting from hl-7 updates when the cache disk is almost full. in an unlikely event that the cache disk is almost full (<100mb) and hl-7 update events are received, the update action fails and an empty path name is written to the ea database. as a result the instance is not deleted from the storage device but no longer referenced. when trying to retrieve the instance an error is returned.
  • 조치
    URGENT MEDICAL DEVICE CORRECTION letters dated November 16, 2012 and April 19, 2013, were sent to all affected customers.The letters requested that customers verify that all Enterprise Archive partitions have enough free space available and that the cache disk has at least 10% free space available. The letters further requested that customers whose disks are not being purged to the configured watermarks and the cache disk is almost full to contact their local GE service person. A permanent product correction (Service Pack 12 and release notes) will be provided by GE Healthcare IT. Customers with questions can contact their GE service representative or the GE Healthcare IT Remote Online Center Customer Care Center at 1-800-437-1171.

Device

  • 모델명 / 제조번호(시리얼번호)
    Version: 3.0.x
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • 제조사 모회사 (2017)
  • Source
    USFDA