Events

Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Designs for Vision Aust Pty 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-01424-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01424-1
  • 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 manufacturer, oculus optikgeräte, has identified recently that when a specific workflow sequence for performing the power calculation is utilised, the coloured display of the quality specification (qs) value changes from yellow to white, while the output values remained the same. the result is that the interpretation of the data, by solely considering the qs value, changes from “check the measurement results; repeating the measurement by having any doubts” (yellow flagged) to “the measurement is ok” (white flagged). although the device has a secondary warning (plausibility check) whereby the software flags any axial length difference greater than 0.3mm, indicating with a warning and displaying the suspicious difference of the axial length, the company has determined that in rare cases, this workflow sequence could result, in displaying an erroneous output. there have been no injuries as a result of this issue.
  • 조치
    Paragon Care is providing users with a software upgrade as a permanent correction.

Device

Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13
  • 모델명 / 제조번호(시리얼번호)
    Pentacam AXL, with software versions 1.21r01, 1.21r03, 1.21r11 and 1.21r13Serial Numbers: 0031 7130, 2721 6111, 3821 7110ARTG Number: 175820 (Designs for Vision Aust Pty Ltd - Corneal topography system)
  • Manufacturer
    Designs for Vision Aust Pty Ltd

Manufacturer

Designs for Vision Aust Pty Ltd