Events

Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems (USA) 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
    17514
  • 사례 시작날짜
    2014-10-10
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    This field safety notice to inform customers that software was upgraded from version 3.X to version 4.0.0 / 4.0.1, the protocol conversion can result in incorrect scan parameters, which in turn can result in delayed images, when using the cct option. report that first image was marked as "last shot" rather than the actual "last shot" acquired. after the clinician pressed the pedal for first exposure, images were displayed as the "last shot". subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labeled as the "last shot". eventually all images appeared., the problem is caused by incorrect slice increment settings in the user set for cct protocol resulting from the protocol to exam card conversion during the software upgrade from v3.X to v4.0.0 / v4.0.1.
  • 조치
    Manufacturer to issue advice regarding use

Device

Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

Manufacturer

Philips Medical Systems (USA)
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA