Equipment for angiography ALLURA XPER, brand PHILIPS, Risk class: III, model: ALLURA XPER FD10 (floor), ALLURA XPER FD10 (ceiling), ALLURA XPER FD20 (floor), ALLURA XPER FD20 (ceiling), Registry: 10216710153; ///// ALLURA XPER ANGIOGRAPHY EQUIPMENT, model: ALLURA XPER FD10 / 10; ALLURA XPER FD20 / 10; ALLURA XPER FD20 / 20; ALLURA XPER FD 20/15; ALLURA XPER FD10 / 10 OR Table; ALLURA XPER FD20 / 10 OR Table; ALLURA XPER FD20 / 20 OR Table; ALLURA XPER FD 20/15 OR Table .. risk class III, registration 10216710206. 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
    1741
  • 날짜
    2015-11-09
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    The manufacturer makes it clear that real-time images and still images can lead to misinterpretation of still images as real-time images. The system is working according to the specification and purpose of the use.
  • 원인
    According to the record holder, the use of the allura xper, allura clarity, allura cv, allura centron and uniq systems in real time and still images can lead to misinterpretation of still images as real-time images. this can happen when: /// 1. when performing fluoroscopy, the user presses the single-shot exposure pedal, resulting in the display of a single-shot static image on the screen. the user does not realize that the single-shot exposure pedal is still active, and that exposure is therefore still active. conceptually, exposure image acquisition has priority over fluoroscopy imaging, so fluoroscopy is not started until the exposure pedal is released. at the same time, the user does not realize that real-time x-ray image acquisition is not active, although the static image icon is displayed and all legally required real-time x-ray indicators (such as dose, active x-ray icon, fluoro timer, and audible signal-x-ray company) are inactive. 2. while a fluoroscopy pedal is pressed and the fluoroscopy is active, the user (accidentally) presses a second fluoroscopy pedal and then releases the first fluoroscopy pedal. by releasing the first fluoroscopy pedal, the system terminates image acquisition in real time. the user does not realize that the first pedal was still pressed by pressing the second fluoroscopy pedal. at the same time, the user does not realize that real-time x-ray image acquisition is not active, although the static image icon is displayed and all legally required real-time x-ray indicators (such as dose, active x-ray icon, fluoro timer, and audible signal-x-ray company) are inactive.
  • 조치
    The field action deals with the sending of Safety Notice for customer orientation. The warning gives the following recommendations to the customer / user: • The user must ensure that the audible signal (X-ray company) is activated. • The user must be aware of the indicators related to the X-ray, ) as described in the instructions for use (IFU). // • The user must activate only ONE fluoroscopy pedal at a time. // • To avoid the simultaneous use of two fluoroscopy pedals, the predicted measurements are working for all pedal models and available for use with the system. // • Users are strongly advised to set the foot switch to the default setting of Philips. // • The user must be aware that pressing a single-shot exposure pedal results in the display of the static exposure image while the single-shot exposure pedal is pressed as described in the instructions for use (IFU) .//// Philips reminds customers to only use one fluoroscopy pedal at a time. Action code: FCO 72200276.

Manufacturer