Events

ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hill-Rom 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-01108-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01108-1
  • 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
    Hill-rom has become aware of a possible hazardous situation when silicon oil contained in the vario sensor within the clinactiv therapy surface is accidentally released. when the pocket of silicone oil is subjected to excessive mechanical stress, it may disconnect and leak oil outside the mattress enclosure and onto the floor.
  • 조치
    Hill-Rom is providing additional cleaning instructions on cleaning silicon oil from affected surfaces, and advising users to ensure the Vario sensor is replaced every 3 years. This action has been close-out on 11/02/2016.

Device

ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the preve...
  • 모델명 / 제조번호(시리얼번호)
    ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)Model Number: N02050, N02051, P02062, P02063, P02064, P02065All Serial Numbers affectedARTG Number: 130272
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd