Events

Intelerad InteleradPACS 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Intelerad Medical Systems Incorporated 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
    18563
  • 사례 시작날짜
    2015-05-22
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Pharmaceutical Marketing New Zealand Ltd, 162 Nile Road, Milford, Auckland 0620
  • 원인
    Images successfully transmitted to intelepacs may not be available for reading in all studies. this failure can be detected if the client has image count verification protocols. this failure can also be detected if complete series are missing as the user will know to look for those missing series. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy, which is also highly detectable. however, under certain circumstances it can appear as if the study is complete with no user observable means to identify the failure. no patient incident has been reported to date.
  • 조치
    Software to be upgraded

Device

Intelerad InteleradPACS
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Software versions: 4.7.1 R27 and up, 4.8.1 R20 and up, 4.9.1 R17 and up, 4.10.1 R9 and up, 4.11.1 R3 and up
  • Manufacturer
    Intelerad Medical Systems Incorporated

Manufacturer

Intelerad Medical Systems Incorporated