Events

Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carestream Health Australia Pty Ltd 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-00501-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00501-1
  • 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
    Carestream health has identified a software issue related to image orientation. if the image suite software receives a computed tomography (ct) or magnetic resonance (mr) image with the image orientation (patient) tag specified, and the overlay is configured to display this tag, the left (l) and right (r) and anterior (a) and posterior (p) overlay text will be displayed opposite. that is, the left side is marked r and the right marked l and the anterior marked p and the posterior marked a. this could result in delays in a misdiagnosis or improper patient care.There has not been any diagnosis errors reported.
  • 조치
    Carestream Health Australia will contact the affected customers to update the software on the device to correct this issue. In the interim, until the software update has occurred, customers who use Image Suite for CT or MR images should make users aware of the problem and take additional steps to check correct orientation of any markers. A review of past patients’ results is recommended at the discretion of the clinical director/radiologist.

Device

Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)I...
  • 모델명 / 제조번호(시리얼번호)
    Image Suite Software Versions 3.0 and 4.0 (Radiology picture archiving and communication system)Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store)ARTG number: 172338
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd