GETINGE WD15 Claro - Washer Disinfector 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-2018-RN-00829-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-27
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Getinge have identified a possible water leakage on limited washer disinfectors of model type wd15. if this issue occurs, both an acoustic and visual alarm ("a03 over flow co" on the machines display) will be present. this leakage may take place during operation in the last part of the cleaning and disinfection cycle. the leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 l/min). if users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. there is also a risk for property damage from the water leak.To date, no injuries have been reported as a result of this issue.
  • 조치
    Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available. In the interim, users may continue to use the washer, provided that the machine is not left unattended. Users should react to device alarms immediately. If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following; 1. Switch off the main switch; 2. Close shut off valves in the water supply lines; and 3. Contact a service technician.

Device

  • 모델명 / 제조번호(시리얼번호)
    GETINGE WD15 Claro - Washer DisinfectorSerial Numbers: WAA083548 and WAA082736ARTG Number: 125655(Getinge Australia Pty Ltd - Washer, decontamination, utensil)
  • Manufacturer

Manufacturer