Events

cardiovascular X-ray systems 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited 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
    I1606-262
  • 사례 연번
    2008EBC-0002432
  • 날짜
    2016-06-28
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer informs that some power cables could be subject to an increase in the probability of failure, which could result in the sudden loss of the function of images or mechanical movements, depending on the subsystem to which it is feeding, leading to the presentation of potential adverse events. patients and users or delays in the procedure.

Device

cardiovascular X-ray systems
  • 모델명 / 제조번호(시리얼번호)
    ALLURA XPER SERIES, software version R8.2, specific serials.
  • 제품 설명
    Monoplane or biplane systems used for diagnostic and interventionist cardiovascular procedures, which have a stand with arm inC suspended from the ceiling and digital image acquisition technology. Indicated for the diagnosis of cardiovascular diseases. It can also be used for diagnosis in surgical procedures and treatment for the placement of stents, demarcated implants in people of all ages.
  • Manufacturer
    Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited

Manufacturer

Philips Medical Systems Nederland B.V. || Philips Electronics India || Philips India Limited
  • 제조사 모회사 (2017)
    Philips
  • Source
    NIDFSINVIMA