Events

Akron Tilt Table couches 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Arjo 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-2018-RN-00605-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00605-1
  • 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
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a complaint related to akron tilt table middle section frame breakage. the investigation showed that one of the critical welds was missing. not all devices are affected by this defect, however, this issue is seen as a potential hazard and arjo australia seeks to prevent the possibility of any related event occurring again.There was no injury related to this incident.
  • 조치
    ArjoHuntleigh is requesting customers: Complete and sign the Customer Response Form supplied with the customer letter and return this form to the local ArjoHuntleigh office as per the directions given. An ArjoHuntleigh Service person will contact the person you listed on the Customer Response Form to schedule service to verify and (if needed) rework your device, free of charge.

Device

Akron Tilt Table couches
  • 모델명 / 제조번호(시리얼번호)
    Akron Tilt Table couchesSerial Numbers: P0167499 and P0418644Model Numbers: A8652 and A8652TProduct Codes: A8652 and A8652TARTG Number: 288419(Arjo Australia Pty Ltd - Table, examination/treatment)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA