Events

Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-2013-RN-01075-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01075-1
  • 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
    Investigations have shown that the overheating protection system of the heating element may fail to function under certain circumstances. this could result in a burn or respiratory complications as a result of inhaling smoke. the reported overheating events have been confined to the machines. therefore, the probability of occurrence of harm to person based on available evidence is considered remote.
  • 조치
    Getinge is advising customers that a customer service representative will be contacting users to replace the affected overheating protective system. Given the low probability to harm, Getinge is advising that it is considered safe for a normal user who services and uses the machine as intended to continue using the machines while waiting for replacement.

Device

Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination ...
  • 모델명 / 제조번호(시리얼번호)
    Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)Manufactured between 2004 and 2008ARTG Number: 125655
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd