Events

Ingenuity TF PET/CT 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-2013-RN-00891-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00891-1
  • 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
    Three issues were identified that may cause a situation requiring a patient rescan:1. after a surview and low dose ct scan, the system does not show the "enable" button prompt to allow the user to begin the pet scan resulting in the inability to perform the pet scan.2. when navigating to the series field value within the scan parameters pane, the series field value will accept certain characters resulting in the failure of the system to properly process the data and provide a reconstructed image.3. a pet reconstruction failure as a result of an incomplete study.
  • 조치
    Philips Healthcare will be installing a software update v 4.0.3. Until software is upgraded, Philips Healthcare advises users to perform workarounds identified in letter.

Device

Ingenuity TF PET/CT
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity TF PET/CTModel number 882456 Software version: 4.0.0.26636 04-Jan-2013Serial numbers: 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018, 2019ARTG number: 118077
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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