IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7 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-2017-RN-01434-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-27
  • 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
    Intelerad medical systems received a complaint from a client notifying a problem that could occur on the intelepacs software. the issue is triggered when plain text reports from external sources have been modified to be html compatible, and by the presence of the less than (<) character in the report. when viewing a report, the less than character is not present while it was there in the original report received by intelepacs. in other cases, when the character is present in a combination with other characters, parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.There is a possibility that incomplete information is presented to the radiologist or referring physician. the absence of the information in the report could affect the decision made in relation with the patient care.
  • 조치
    Emergo is advising users who utilise reports with HTML from external sources, that the affected issue may occur depending on the HTML formatting provided by the external source. If users are affected, a review of configurations of the external source is recommended. Intelerad is advising users that a configuration change and software upgrade will be implemented as a permanent correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7ARTG Number: 149923
  • Manufacturer

Manufacturer