Events

ARTIS EQUIPMENT FOR ANGIOGRAPHY. ANVISA Registry No. 10345162023. Risk class III. Serial numbers: 154646 (Artis zee biplane); 147531, 147551, 147582, 147600, 147602, 147617, 147619, 147637, 147650, 147706, 147708, 147819, 147826 (Artis zee ceiling); 139013, 137013, 136918, 136933, 136936, 136944, 136947, 136977, 136995, 137020, 137026, 137033, 137042, 137045, 137074, 137083, 137088, 137089, 137090, 137094, 137098, 137099, 137100, 137102, 137143, 137159, 137162, 137161, 137162, 137164, 137182, 137191, 137246, 137281, 137299, 137300, 137310, 137324, 137346, 137379, 137382, 137387, 137411, 137416, 137426, 137436, 137447, 137624, 137658 (Artis zee floor); 160143, 160457, 160836, 160843, 160946, 160976 (Artis zeego). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; Siemens AG; 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
    1842
  • 날짜
    2016-03-30
  • 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 company "Recommends users of the target devices of this field action to wait until the Siemens engineering team schedules a field visit so that the problem is definitely corrected."
  • 원인
    Siemens healthcare informs that field action ax075 / 15 / s & ax076 / 15 / s addresses two possible mutually independent causes of a system defect. a) in artis zeego systems, angles around the collision area of ​​arm c can obstruct cable entry, resulting in mechanical damage. b) in artis systems with a100plus generators, an attempt to resume operation after detecting a fault (such as a short-circuit in the x-ray light bulb) may cause a module failure in the high-voltage generator.
  • 조치
    The field action code AX075 / 15 / S & AX076 / 15 / S initiated by Siemens deals with a field correction, software update, by prior letter of the client, with risk classification III (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences). Recommendation to Users and Patients: We recommend that users of the target devices of this field action wait until the Siemens engineering team schedules a field visit so that the problem is finally corrected.

Device

ARTIS EQUIPMENT FOR ANGIOGRAPHY. ANVISA Registry No. 10345162023. Risk class III. Serial numbers:...

Manufacturer

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