Events

Spectra Optia Apheresis System - Return Line Air Detector (RLAD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Terumo BCT 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-00886-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00886-1
  • 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
    Terumo bct has redesigned the return line air detector (rlad) component of the spectra optia apheresis system. this redesign will further reduce the low occurrence of false air detections during a procedure; the plan has been to install the replacement component on devices in which a rlad false air detect has occurred.
  • 조치
    Terumo BCT is replacing the existing RLAD sensor with the redesigned component on all Spectra Optia systems in Australia. If false air detections have occurred on a system in the last 12 months the upgrade will be scheduled as soon as possible. Where no issues have been reported the RLAD sensor will be replaced during the next scheduled preventative maintenance visit. This action has been closed-out on 03/05/2016.

Device

Spectra Optia Apheresis System - Return Line Air Detector (RLAD)
  • 모델명 / 제조번호(시리얼번호)
    Spectra Optia Apheresis System - Return Line Air Detector (RLAD)ARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd