Events

STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tables 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-00884-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00884-1
  • 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
    Steris has determined there is a potential that if the surgical table feet become unlocked from the floor during a procedure, the hand control may incorrectly indicate that the table feet are locked and still contacting the floor. the user may not realise that the table is unlocked and is able to continue articulating the table using the hand control. no patient injury or adverse health outcomes have been reported due to this issue.
  • 조치
    Should this occur, users are advised that the table can be relocked by pressing the Floor Lock button on the table hand control. As soon as parts are available a Device Technologies representative will contact customers to schedule the installation of new hardware and updated software on all affected Surgical tables. In addition, a new copy of the 4085 Surgical Table Operator Manual will be provided during this site visit. Users may continue to operate all 4085 series surgical tables prior to the completion of the update. This action has been closed-out on 19/08/2016.

Device

STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tables
  • 모델명 / 제조번호(시리얼번호)
    STERIS 4085, 4085 SS and 4085 Feather Weight Leg Section (FLWS) Surgical tablesProduct Codes: ST-01-360-1, ST-01-380-1 and ST-01-360-7All batches manufactured between 3 July 2009 and 20 June 2014Multiple affected serial numbersARTG number: 149156
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd