Events

CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carl Zeiss 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-2018-RN-00350-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00350-1
  • 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
    It has been identified that it is possible for the clarus 500 to allocate patient data to the wrong patient. this may occur when the operator exits the acquire page to the patient management page while the system is in process of creating the montage of two or more images. the constituent images from which the montage is derived are still assigned to the correct patient. they can be viewed individually or manually montaged to recreate the missing information. the error is detectable as there will be no constituent image to support the montage for the affected patient.
  • 조치
    Zeiss will be conducting a software update by the ZEISS Service Centre and important changes to the User Manual for CLARUS 500 which has already been supplied to users. A software update is available for the CLARUS 500 and updated user manual is available accordingly. The update only applies to CLARUS 500 devices with software versions 1.0.0, 1.0.1, and 1.0.2.

Device

CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2
  • 모델명 / 제조번호(시리얼번호)
    CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2ARTG Number: 295240Carl Zeiss - Camera, fundus
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd