Events

Ceiling Unit CU5001/3 and CU 3-21/23 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia 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-01286-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01286-1
  • 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 microscope arm of specific ceiling units can be electrically driven from the parked position into the operating field by an electromotive lifting column. the manufacturer moller-wedel has identified that abrasive wear of the drive assembly can occur which could cause a slide-through of the telescopic column into the lowest stop.The microscope arm can be moved upwards and downwards with a levitation height of 40cm by a motorised adjusted telescopic column. if severe abrasive wear occurs the lifting column can slide downwards during lifting procedures up to 40cm onto the lowest stop.
  • 조치
    Device Technologies is advising users to move the telescope column to the lowest position for use without restrictions. Users should attach provided labels to the ceiling unit to indicate that the lifting column is in the lowest position until service has been performed.

Device

Ceiling Unit CU5001/3 and CU 3-21/23
  • 모델명 / 제조번호(시리얼번호)
    Ceiling Unit CU5001/3 and CU 3-21/23Product Code: CU 5001Reference Number: 604 105Serial Numbers: from P51 up to 274Product Code: CU 5003Reference Number: 604 106Serial Numbers: from P51 up to 127Product Code: CU 3-21Reference Number: 604 650Serial Numbers: from P51 up to P58Product Code: CU 3-23Reference Number: 604 700Serial Numbers: from P51 up to P60ARTG Number: 267878
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd