Events

Invivo Expression MRI Patient Monitoring System - Product 865214 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-00597-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00597-1
  • 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
    The device's labelling inaccurately indicates “endotracheal” as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.
  • 조치
    Philips is advising end users that the FlexTEMP reusable temperature sensor cannot be in endotracheal site. Philips is working to correct this labelling issue and will contact customers with an update on its implementation plan. This action has been closed-out on 09/08/2016.

Device

Invivo Expression MRI Patient Monitoring System - Product 865214
  • 모델명 / 제조번호(시리얼번호)
    Invivo Expression MRI Patient Monitoring System - Product 865214Units Affected - Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 - US42708744). Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this medical device correction.ARTG Number: 189095
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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