Events

Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Affected Model: Artis zeego, Artis zee biplane, Artis zee ceiling, Artis zee floor, Artis zee Multi-purpose Serial Numbers affected: 147551; 147708; 136918; 136933; 136947; 137020; 137026; 137042; 137045; 137074; 137105; 137164; 137379; 137411; 137658; 160457; 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
    2081
  • 날짜
    2016-12-06
  • 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
    It is possible for Megalix X-ray tube systems to perform focussed acquisition of images after manual selection of a corresponding organ program. In 3-spot Megalix X-ray systems, fluoroscopy is possible with the "small" or "micro" focus that is still intact through the manual selection of a corresponding fluoroscopy program. In addition, the acquisition of images with the big focus is possible. Standard emergency procedures must be in place in case of system failures. Consider reinforcing these procedures until the upgrade has been made.
  • 원인
    For artis systems with software versions vc21c and vd11 and megalix cat + x-ray tubes, the semi-automatic focus switch may, in cases of defects in the "small" and "micro" foci (if present), not work as intended when pressing the pedal. this type of focus defect, which causes the failure of the semiautomatic focus switch, becomes more likely as the life of the x-ray tube increases. as a matter of clarity, systems with the vc21b software version do not are affected.
  • 조치
    Field Action Code AX050 / 16 / S & AX051 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registrati...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens AG.