Events

Spot Vision Screener 100 with software version up to and including 3.0.01.07 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Welch Allyn Australia Pty Limited 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-00138-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00138-1
  • 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
    If the device is not used or charged every five months, the coin cell battery that maintains the system clock may become depleted. once the coin cell battery has depleted, the system clock will reset to a date in the past (date of the last installed software release for example). this may cause the patient age to be calculated incorrectly. please note, the patient age is used by the spot vision screener 100 to determine referral criteria for certain screening conditions–specifically anisometropia, myopia, astigmatism and hyperopia. an incorrect patient age could result in an incorrect (either under or over) referral recommendation.
  • 조치
    Welch Allyn is recommending users review new software releases and determine if the device should be updated. Software updates can be downloaded at www.welchallyn.com.au. In the interim, users are advised to refer to the additional instructions to re set the system clock if the issue occurs.

Device

Spot Vision Screener 100 with software version up to and including 3.0.01.07
  • 모델명 / 제조번호(시리얼번호)
    Spot Vision Screener 100 with software version up to and including 3.0.01.07Model Number: Model VS100ARTG Number: 293205Welch Allyn Australia - Visual function analyser
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited