Events

Equipment for angiography Artis, models Artis zee ceiling; Artis zee floor; Artis zeego, registration 10234230190, hazard class III, lots / series: 135297; 135329; 135785; 135816; 135825; 135835; 135848; 135869; 135941; 135969; 135980; 135984; 135991; 136056; 136060; 136068; 136115; 136119; 136136; 136144; 136199; 136213; 136214; 136276; 136282; 136283; 136284; 136285; 136288; 136301; 136320; 136355; 136363; 136369; 136373; 136419; 136421; 136424; 136425; 136440; 136443; 136457; 136492; 136580; 146646; 160143; 160343; 160360; 160467. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Ltda.; SIEMENS AG. 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
    1652
  • 날짜
    2015-07-24
  • 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
    Considering the problem related to the locking of the system in the "Fluoro Bypass" mode, it is possible that there is no radiation release and no fluoroscopic images are acquired. The risk would be more related to the delay due to the system restart. In the second problem presented the risk are related to the possible unexpected movement of the equipment resulting in collision.
  • 원인
    Two problems with the system have been described by the company that holds the registry: the first would be in case of an error in the equipment and it is in the "bypass fluoro" mode, while the x-ray blocking function is active, it will not be the only way out of this function is to solve the root cause of the equipment being in the "bypass fluoro" mode or to restart the system. the other problem is related to the possible failure of the position sensor on the articulated base axis that is not detected by the system software. following activation of operator movement, the c-arm system may move unexpectedly faster than normal.
  • 조치
    The company intends to continue to use the equipment until the company engineer's visit is made for field correction of the equipment. The field correction corresponds to the software update by installing two packages (11 and 12).

Device

Equipment for angiography Artis, models Artis zee ceiling; Artis zee floor; Artis zeego, registra...

Manufacturer

Siemens Ltda.; SIEMENS AG.