Events

Trade name: /// (1). EQUIPMENT FOR ANGIOGRAPHY ARTIS (Record 10345162023) - Models: (i). Artis zee floor; (ii). Artis zee ceiling; (iii). Artis zeego; (iv). Artis Q biplane; (v). Artis zee biplane /// (2). AXIOM ARTIS FC AXIOM (Record 10234230075) - Model Artis FC /// (3). AXIOM ARTIS FA AXIOM (Record10234230093) - Model Artis FA /// (4). AXIOM ANGIOGRAPHY EQUIPMENT (Registration 10234230096) - Models: (i). Artis dFA; (ii). Artis dFC ### Technical Name: Angiography Equipment ### ANVISA Registration Number: (1). ARTIS EQUIPMENT FOR ANGIOGRAPHY (Record 10345162023) /// (2). AXIOM ARTIS FC AXIOM (Registration 10234230075) /// (3). AXIOM ARTIS FA AXIOM (Registro10234230093) /// (4). AXIOM ANGIOGRAPHY EQUIPMENT (Registration 10234230096) ### Risk Class: III (High Risk) ### Affected Series Numbers: APPENDIX 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 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
    1972
  • 날짜
    2016-08-25
  • 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
    Recommendation to Users and Patients: Siemens recommends users to place an additional external filter in the water circuit, which will implement a protection mechanism to prevent functional failure of the pump system as a result of contamination. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • 원인
    Possible cause of system defect due to contaminants in the form of biomass that can develop in the cooling system of the artis systems, resulting in damage to the pump system. the presence of contaminants in the tube cooling circuit impairs the performance of the pump. this failure may even lead to a functional failure of the system. the tube assembly may become superheated so that no radiation can be released.
  • 조치
    Field Actions No. AX006 / 15 / S & AX007 / 15 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA deal with a correction in the field, correction of parts / pieces, by means of previous letter sending to the client.

Device

Trade name: /// (1). EQUIPMENT FOR ANGIOGRAPHY ARTIS (Record 10345162023) - Models: (i). Artis ze...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare GmbH