Events

Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical Vision Aust Cardiology & Thoracic 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-2015-RN-00715-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00715-1
  • 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
    Volcano corp. has discovered a very specific workflow scenario where the aortic pressure (pa) offset used in the ffr/ifr modalities will be lost or reset to 0 mmhg due to a software error. this issue can lead to an inaccurately calculated ffr or ifr value. should this occur, a clinician may rely on an inaccurate value in diagnosing a patient's condition. if the pa was not zeroed through the volcano system as part of the workflow, this software issue has no impact on the ffr / ifr values or on the patient.
  • 조치
    Medical Vision Australia is advising their customers that if zeroing Pa is warranted, as described in the FFR Option Operator's Manual, performance of this product cannot be assured until the software update is provided. A Medical Vision Australia Representative will contact affected hospitals to schedule a correction to the software in the next few weeks. This action has been closed-out on 24/08/2016.

Device

Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (wit...
  • 모델명 / 제조번호(시리얼번호)
    Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE SeriesSoftware versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits
  • Manufacturer
    Medical Vision Aust Cardiology & Thoracic Pty Ltd

Manufacturer

Medical Vision Aust Cardiology & Thoracic Pty Ltd