Events

CT Scanner Equipment INGENUITY; Brand Philips; Risk class III; registry: 10216710209; Serial numbers: 31001/32054/32065/32067/52067/52010/52030/52031/52044. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1562
  • 날짜
    2015-04-02
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    According to the company during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have the real-time feedback of the needle placement when it is close to the vital structures (large vessel, organ, etc.). .). #### UPDATED ON 07/18/2017, the company sent the completion report of the field action proving the accomplishment of correction, as planned.
  • 원인
    According to record holder information, "during the conduct of the tcc in the ingenuity ct system, the first image was marked as" last capture "instead of the current" last capture "acquired. by pressing the pedal for the first exposure, the images were displayed as the "last shot". subsequent requests did not result in an immediate reconstruction of the image and the first image remained on the screen identified as the "last capture". eventually all images appeared. the problem is caused by incorrect settings for increasing the number of slices in the user set for the tcc protocol resulting from the conversion of the protocol to the exam card during software upgrade from v3.X to v4.0.0 / v4.0.1. in normal tcc mode, the images are reconstructed without delay and the "last capture" is displayed properly with the last reconstructed result. ".
  • 조치
    The record holder's recommendations, affected users should check the TCC examination card and correct it if this problem exists. The guidance is to refer to the steps in the Addendum to the safety notice (see annex).

Device

CT Scanner Equipment INGENUITY; Brand Philips; Risk class III; registry: 10216710209; Serial numb...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA