Events

Aidacare FL250 Bed, Single and King Single 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Aidacare 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-00840-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00840-1
  • 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
    Aidacare has identified a labelling error pertaining to electrical classification on the manufacturer id sticker – it is shown as class ii device when the device is class i. this mislabelling creates the potential for testing and tagging to be incorrectly administered on fl250 beds.The class is labelled correctly on the control unit under the bed.
  • 조치
    Aidacare is advising that they will contact impacted customers to arrange for on-site correction.

Device

Aidacare FL250 Bed, Single and King Single
  • 모델명 / 제조번호(시리얼번호)
    Aidacare FL250 Bed, Single and King SingleProduct Codes: BEB046100 (Single) and BEB046150 (King Single)Dates of Manufacture – 22 June 2017 to 17 May 2018ARTG Number: 287924(Aidacare Pty Ltd - Bed, disabled person, electrical)
  • Manufacturer
    Aidacare Pty Ltd

Manufacturer

Aidacare Pty Ltd