Events

INTELEPACS Version 3.8.1 and up (Radiology 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-2014-RN-00662-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00662-1
  • 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 inc. following internal testing, is providing additional information regarding the proper usage of the intelepacs software. this issue relates to the compression of images into jpeg 2000 (2c) format. in specific circumstances, when writing image data to storage that has filled up, the image data may become truncated.
  • 조치
    In order to correct this issue, a new software release will be installed on affected systems. Intelerad will run an audit on the entire PACS to identify all image data that may be truncated. For any affected studies, Intelerad will be able to restore a full fidelity image if required by the customers. This action has been closed-out on 29/01/2016.

Device

INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia