Events

Mobile Shower and Toilet Commode Aquatec Ocean VIP 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Invacare 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-2014-RN-00518-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00518-1
  • 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 manufacturer has advised that during regular market observation they noticed that some of the snap-on fixtures do not withstand the required pull out force. this was caused due to an inconsistency of the injection moulding, and did not meet the design specification for the snap-on fixtures. the male portion of the clip has a 90-degree angle overhang; and this was not completely filled as per specification. the attachment mechanism has the potential to unintentionally open when the product is used in the recline position.
  • 조치
    Invacare is requesting the device providers to locate all affected Mobile Shower and Toilet Commode Aquatec Ocean VIP and replace the faulty clips. Further information on this recall action can be found on the TGA website at http://www.tga.gov.au/safety/alerts-device-aquatec-ocean-vip-mobile-shower-toilet-commode-140522.htm . This action has been closed-out on 04/04/2017

Device

Mobile Shower and Toilet Commode Aquatec Ocean VIP
  • 모델명 / 제조번호(시리얼번호)
    Mobile Shower and Toilet Commode Aquatec Ocean VIPMultiple serial numbers affectedARTG Number: 153914
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd