Events

Getinge HS33 Sterilsers 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-2017-RN-00251-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00251-1
  • 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
    Getinge has identified an issue with getinge hs33 manual door sterilisers, which can potentially cause the door with manual mechanism to unseal during the process. this can cause potential steam leakage. this potential for malfunction is caused by the design of the door hook which is a part of the door locking mechanism (part number 4839900). when the door has been closed and the sterilisation process has started, the leak may occur through the door gap, however the door will not slide down as the clamping brakes located on both sides of the door hinder the slide down. in case the process must be interrupted due to safety reasons, the emergency stop button will immediately cut off steam supply to the chamber. getinge's investigation which included risk analysis and evaluation of the worst-case scenario concluded that it is highly unlikely the malfunction would cause or contribute to an injury.
  • 조치
    Getinge has developed a new design of the component (part no 6011000223) to prevent device door to unseal during the process. This action is to replace the existing door hook (part no 4839900) with the new and corrected design.

Device

Getinge HS33 Sterilsers
  • 모델명 / 제조번호(시리얼번호)
    Getinge HS33 SterilsersModel Numbers: 978053XXX, 978055XXX and 6011978043XXXSerial Numbers: 11101581, 12031135, 12171741, 12481961, 13122119, 13402211, 13412218, 13412224, 13452238, 14483126ARTG Number: 275198
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd