Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (picture archiving and communication 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-00872-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-07
  • 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 action has been initiated because the cross reference lines a.K.A. cut lines or localiser lines may not display properly. this is due to math error when calculating the cut line position for studies with extremely high precision in the dicom tag image orientation patient (0020,0037) containing values of greater than 15 significant digits. the patient tag on affected images includes the value "e-16". when the problem is encountered the cross reference lines will move erratically as the user stack scrolls through the study. this may impact diagnosis when images are unavailable for viewing.
  • 조치
    Merge is working on correcting the issues and will inform customers once a fix is available. In the interim, users are advised that in order to view the study with the cross reference lines, it is recommended to view the study on another workstation of the modality device. Also, examine the image orientation patient tag to see if there are values with "e-16" included to see if a study in question could be affected. This action has been closed-out on 27/02/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (picture archiving and communication system)ARTG Number: 191068
  • Manufacturer

Manufacturer