Events

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. Serial numbers: 400294. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA Inc 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
    1845
  • 날짜
    2016-04-01
  • 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
    Alignment failure can result in system blocking, causing an interruption of the procedure in progress. However, the company stresses that this problem does not influence the treatment of patients.
  • 원인
    Siemens healthcare diagnostics sa informs that the field action us028 / 15 / s deals with a bevel alignment problem on the front panel, the plastic cover around the transducer ports prevents complete contact of the connector in the transducer to the port of the transducer. transducer in the system, resulting in system blocking.
  • 조치
    The field action code US028 / 15 / S initiated by Siemens deals with a correction in the field, correction of parts and pieces, by means of previous sending of letter to 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: 1. In the case of a transesophageal transducer that has been inserted in a patient, we recommend the user first disconnect and reconnect the transducer. 2. If the system remains locked, the user must follow the on-screen instructions and disconnect the transducer, remove it from the patient and contact a Siemens service representative.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. S...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA Inc