Events

Getinge VOLISTA StandOP and TRIPOD surgical lights 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-00282-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00282-1
  • 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
    Getinge has identified an issue causing failure of the control keypad resulting in the cupola not turning on or off. a review of complaint data has demonstrated that this issue has occurs in 3 different keypad versions. this potential for malfunction is caused by an internal frequency issue of a component on keypads version 1, and by the touch-sensitive technology that was not sensitive enough on versions 2 and 3. the keypads at fault are no longer produced. getinge have implemented a more robust keypad using a different technology. this action is to replace the potentially defective keypads with the new keypad.To date, no injuries as a result of this issue have been reported.
  • 조치
    Getinge is advising they will contact affected users to schedule a service to replace any potentially defective keypads with the new keypad.

Device

Getinge VOLISTA StandOP and TRIPOD surgical lights
  • 모델명 / 제조번호(시리얼번호)
    Getinge VOLISTA StandOP and TRIPOD surgical lights Model Codes: VOLISTA 400 and VOLISTA 600Manufactured before June 2017Keypad Part Number: ARD568801560Up to Serial Number: 540000Device Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960, ARD568821963, ARD568822960, ARD568822963ARTG Number: 162037(Getinge Australia - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd