Events

STERIS 5085 and 5085SRT Surgical Table 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-01185-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01185-1
  • 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, steris corporation, has learned through customer feedback and field service experience that the shroud cover for the hydraulic column may become misaligned and damaged as a result of extreme articulation or excessive pressure on the side or base of the table. in most instances, the shroud damage is minor and does not affect the vertical up/down movement of the hydraulic column. in cases of sever shroud damage, the shroud sections may become misaligned such that vertical movement of the hydraulic column is impeded. no patient injury or adverse health outcomes have been reported due to this issue.
  • 조치
    Device Technologies Australia (DTA) representative will contact the customer to arrange an upgrade to correct the problem. DTA is also advising customers that the 5085/5085SRT Surgical Tables can continue to be operated in the interim. This action has been closed-out on 11/08/2016.

Device

STERIS 5085 and 5085SRT Surgical Table
  • 모델명 / 제조번호(시리얼번호)
    STERIS 5085 and 5085SRT Surgical Table Product codes: ST-01-410-1, ST-01-460-7, ST-480-7 and ST-01-480-06 Serial Number Range: 0403809001-0425514019ARTG number: 149156
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd