Events

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 80015490090 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee biplane, Artis Zeego, Artis Q biplane 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; 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
    2209
  • 날짜
    2017-03-06
  • 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
    Users should notify and instruct their teams to be aware of this problem and if there are any questions regarding the addendum to the operating instructions, the company should be contacted.
  • 원인
    Siemens healthcare diagnostics informs that in the indicated artis systems a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear on the "small" and "micro" (if present) focus, an automatic focus is performed when the pedal is pressed several times. this special system function is not fully written in the currently available operating instructions. if a focus (small / micro) develops a fault, an alternative focus can be selected by pressing the pedal repeatedly. this allows the radiation to be generated again so that clinical treatment or diagnosis can proceed.
  • 조치
    Field Action Code AX058 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will update, correct or supplement the instructions for use.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 800...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG