FerriScan (software for determining liver iron concentration from MRI images) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Resonance Health Analysis Services 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-01233-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-09-20
  • 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
    It has been identified that there is a misprint in the liver iron concentration (lic) measurement units on a subset of ferriscan reports. the report should include the average liver iron concentration result in mg/g dry tissue on the first line of the report and in mmol/kg dry tissue on the second line. this misprint only affects the second line result, where mg/g dry tissue is displayed rather than the correct units of mmol/kg dry tissue. the correct value (number) is displayed. the first line has both the correct value (number) and correct measurement units. an investigation by resonance health determined that the misprint only occurred in specified reports where the lic value was greater than 43 mg/g of dry tissue. as such, the misprint for the second line result only occurs in cases of extreme liver iron overload. no other reports are affected.
  • 조치
    Resonance Health is advising those with affected reports of the error in the measurement units and will re-issue reports on the request of users. This action has been closed-out on 10/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    FerriScan (software for determining liver iron concentration from MRI images)Reports with LIC > 43 mg/g of dry tissue and issued between 5 Oct 2105 to 26 Aug 2016ARTG Number: 116071
  • Manufacturer

Manufacturer