Events

Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00474-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00474-1
  • 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
    Philips have found two potential issues that may result in the subframe of the table top becoming free floating and causing unintended, horizontal motion. the two potential issues are:1. service latch may not be properly secured;2. service latch threaded rod may be fractured.There is a risk of serious injury to the patient and operator/technician as a result of the table top free floating. for the patient:· there is a potential for disconnection or movement of invasive medical devicesfor the operator/technician:· there is a potential for pinch point on the subframe; and a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward.
  • 조치
    Philips is advising their customers to stop using the system if horizontal free-floating couch motion is experienced during normal clinical use. The threaded rob will be replaced in all affected devices. This action has been closed-out on 12/02/2016.

Device

Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA