Events

Philips Model AFFINITI 50 Ultrasound System (Intended for diagnostic ultrasound imaging and fluid flow analysis) 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-2015-RN-00411-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00411-1
  • 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
    When affiniti 50 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient’s body surface area (bsa). when using both height and weight to calculate the bsa, which is the usual practice for patients above the age of 2 years, the result may be too high by a factor of about 10, an error that would be readily identified by the user. using patient’s weight only to calculate the bsa would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
  • 조치
    Philips has corrected this issue in software version 1.0.3. which will be provided to users free of charge. Philips has provided work around instructions until the software is implemented. This action has been closed-out on 05/09/2016.

Device

Philips Model AFFINITI 50 Ultrasound System (Intended for diagnostic ultrasound imaging and fluid...
  • 모델명 / 제조번호(시리얼번호)
    Philips Model AFFINITI 50 Ultrasound System (Intended for diagnostic ultrasound imaging and fluid flow analysis)Software Versions 1.0.2 or lower ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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