Merge iConnect Enterprise Archive (iCEA) with software versions 8.80 through 9.4.4 (a picture archiving and communications system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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
    RC-2016-RN-00860-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-30
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    This recall has been initiated because of an error when viewing prior results. a pixel offset issue can occur when prefetching a prior image from the lta to a local cache resulting in the viewer being unable to display it. the original study on the lta is unaffected. in icea version 8.80, the pixel offset algorithm for images changed from absolute to relative offset. in normal operation, the new offset algorithm presents no risk. however, a pixel offset issue can occur when running a heterogeneous mix of icea versions spanning the lta and fic. more specifically, the issue can occur when running a pre-8.80 version of the lta with an 8.80 or later version for the fic. if prior studies are not available for viewing, this may lead to delay in treatment for the patient, however there are no reports of injuries as a result of this issue.
  • 조치
    Merge has a released software fix available for this issue. In the interim, Emergo is advising users of the following workaround. Do not run a mix of pre-8.80 software for LTA and an 8.80 version or later for the FIC. When prefetching, send uncompressed studies from the LTA to the FIC. Restore images manually from LTA using the webadmin tool. This action has been closed-out on 22/02/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Merge iConnect Enterprise Archive (iCEA) with software versions 8.80 through 9.4.4 (a picture archiving and communications system)ARTG Number: 206683
  • Manufacturer

Manufacturer