Events

Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00476-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00476-1
  • 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
    Philips received reports from the field that certain ingenuity core systems running software version 3.5.4 exhibited intermittent swirl-like ring artefacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. a patient rescan may be required due to impairment of the diagnostic quality of the reconstructed images.
  • 조치
    There are no proactive actions for the user. Clinical judgment should be used by the clinician to determine if the images contained in the dataset without artefacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a rescan of the patient may be required. Philips Healthcare is implementing software update version 3.5.5 to correct the above-described issue. This action has been closed-out on 30/01/2017.

Device

Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity Core using software version 3.5.4 (Computed tomography (CT) x-ray diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA