Events

SureSigns VSi, VS2+ products 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-2018-RN-00177-2
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00177-2
  • 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
    Phillip has identified that certain suresigns vsi, vs2+ products labels have a printing error on the date of manufacture.This action supersedes rc-2017-rn-01263-1 regarding an error in printing of the date of manufacture on the same devices.
  • 조치
    Philips is advising that the affected products may continue to be used because this Date of Manufacture information on the serial number label, does not impact any of device function or operation. Philips will provide a new label with no printing error for the Date of Manufacture for each affected unit. An instruction will be provided to the impacted customers on how to perform the correction. A Philips Healthcare representative will contact users to arrange for the correction.

Device

SureSigns VSi, VS2+ products
  • 모델명 / 제조번호(시리얼번호)
    SureSigns VSi, VS2+ products All devices manufactured between December 15, 2016 and May 02, 2017Model: SureSigns VSi - NBPProduct: 863275Model: SureSigns VSi - NBP/SPO2Product: 863276Model: SureSigns VS2+ NBP/SPO2Product: 863278Multiple affected serial numbersARTG: 93971Philips Electronics Australia Patient monitor, multiparameter
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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