Events

EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceiling); FD10OR Table; FD20 OTable; FD10 / 10; FD20 / 20 OR Table; FD20 / 10 OR Table; registry 10216710153 and 10216710206, hazard class III, series affected: 405/377. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V. 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
    1715
  • 날짜
    2015-05-15
  • 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 record holder's information, intermittent failure of fluoroscopy may result in a temporary discontinuation of procedures and delay in treatment. #### UPDATED ON 7/18/2017, the company issued a completed field action report confirming the performance of correction, as provided.
  • 원인
    Software failure that can lead to intermittent and short-term unavailability of the fluoroscopy function.
  • 조치
    The company will update the software, installation of version R8.2.16.1, to correct the problem. The company clarifies that upon initiating fluoroscopy, the user may receive a "Fluoro failed, please retry" message and Fluoroscopy will be unavailable. Fluoroscopy repeat solves this situation in most cases. The user may need to repeat more than once in approx. 2% of events. The failure mode has no impact on the performance of active fluoroscopy. Once started, performing an active fluoroscopy continues until the pedal is released.

Device

EQUIPMENT FOR ANGIOGRAPHY ALLURA XPER, FD10 (ground); FD10 (ceiling); FD20 (ground); FD20 (ceilin...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA