Events

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis Q biplane, Artis Q ceiling, Artis Q floor, Artis Q.zen biplane, Artis Q.zen ceiling , Artis Q.zen floor, Artis zeego Serial numbers affected: 121125 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare GmbH; Siemens Healthcare GmbH 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
    2076
  • 날짜
    2017-01-06
  • 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
    The software problem can be corrected when you restart the system. It may take up to 8 minutes to restart the system. Normal emergency processes should be implemented in the event of a system failure. Ensure that these processes are prepared in advance until the update is applied. ### UPDATED ON 10/26/2017, the company submitted the completion report of the field action proving the sending of the security warning to the client with evidence from the science and all actions completed.
  • 원인
    The notification is intended to inform a corrective measure addressing two possible causes of a system defect and mutually independent. - in artis systems with a100plus or a100g generators, an attempt to resume operation after detecting a fault (such as a short-circuit in the x-ray tube, for example) may result in failure of a module in the high- voltage; - for bi-plane systems with the vd11b software version since april of this year, software problems in conjunction with graphics cards may, in rare cases, result in loss of presentation of images in the examination room.
  • 조치
    Field Action Code AX001 / 16 / S & AX002 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will make Field Correction.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 103...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare GmbH; Siemens Healthcare GmbH