Events

SureSigns VSi, VS2+SureSigns VSi - NBP 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-2017-RN-01263-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-10-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01263-1
  • 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 has identified that certain suresigns vsi, vs2+ products have the date of manufacture on its serial number label as “%dom”, instead of the specific date in the format of yyyy-mm.
  • 조치
    1. Philips will provide affected customers with a new label with "Date of Manufacture" for each unit. An instruction will be provided to impacted customers on how to do the correction. 2. Philips Healthcare will contact customers impacted to arrange for the correction.

Device

SureSigns VSi, VS2+SureSigns VSi - NBP
  • 모델명 / 제조번호(시리얼번호)
    SureSigns VSi, VS2+SureSigns VSi - NBPProduct Number: 863275SureSigns VSi - NBP/SPO2Product Number: 863276 SureSigns VSi - NBP/SPO2/Temp/WirelessProduct Number: 863277SureSigns VS2+ NBP/SPO2Product Number: 863278SureSigns VS2+ NBP/SPO2/WirelessProduct Number: 863279Multiple Serial NumbersARTG Number: 93971
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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