Events

Vadi Heater 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AHC Solutions 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-00041-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00041-1
  • 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
    Ahs solutions p/l has been made aware of an issue regarding overheating of vadi heater vh220 causing shrinkage of the filter due to dysfunction of the cut-off switch. the root cause analysis found that the dysfunction of the switch is due to the distance from the tape to glue the switch to the heating scroll not being attached closely enough. as a result, there is a gap between switch and aluminium heating scroll, which, after a long term use, can damage the switch. the damaged switch will therefore be unable to control the temperature, causing overheating which deforms the filter.
  • 조치
    AHC Solutions is advising users to dispose of VH220 heaters that are currently in use. Customers will be provided with replacement heaters.

Device

Vadi Heater
  • 모델명 / 제조번호(시리얼번호)
    Vadi Heater Part Number: VH220ARTG Number: 212166 (AHC Solutions Pty Ltd - Filter, ventilator)
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd