Events

Device Recall iConnect Access used with Ortho PACS software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merge Healthcare, 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
    74734
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2532-2016
  • 사례 시작날짜
    2016-01-30
  • 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=148348
  • 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
    Studies that are viewed in iconnect access that originate on merge pacs / ortho pacs may not display the correct current patient demographics if there has been a pde (patient / study demographic edit) performed after the images were ingested in pacs.
  • 조치
    The recalling firm issued a letter dated 1/28/2016 via e-mail on 1/31/2016 or via certified mail if they did not have an e-mail address for the customer.

Device

Device Recall iConnect Access used with Ortho PACS software
  • 모델명 / 제조번호(시리얼번호)
    iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • 제품 설명
    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.