Events

Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073 Hazard class: III Serial numbers affected: 5529; 5746; 5828 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 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
    2225
  • 날짜
    2017-03-14
  • 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
    Despite security measures, there may be scenarios that are not covered by the software. Therefore, during automatic sequencing, the operator must pay attention to any movements of the gantry and the treatment table, and deviations or overlaps of the table applied in accordance with the treatment plan and carry out the preventive measures described in the letter of notification TH012 / 14 / S.
  • 원인
    Siemens healthcare diagnostics reports that previous afs motion protection software considered only the critical definitions of isocentric and eccentric table positions, but not a lateral deviation from the treatment table. in addition, the previous software required that the table setting be set to "automatic" in all parameters. if the operator had set the table's isocentric rotation to "manually" and the order of movements to "table first", the previous software ignored this setting. if a move from the gantry and the table to the next treatment field was required, the software did not stop the afs so as to allow manual table movement before the gantry moves, which would be automatically moved to the next target position.
  • 조치
    Field Action Code TH005 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration numb...

Manufacturer

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