Events

Commercial Name: PETROLEUM TOMOGRAPHY EQUIPMENT BY PETROLEUM (PET) / COMPUTERIZED TOMOGRAPHY (CT) BIOGRAPH; Model: Biograph mCT Flow; Biograph mCT Flow Edge; Biograph mCT-S; Biograph mCT-X; Biograph 6 TruePoint; Biograph 40 TruePoint; Biograph 64 TruePoint; Biograph 16; Biograph 16 TruePoint; Anvisa record: 10234230170; risk class III; lots / series under risk: 1042; 1066; 1070; 1095; 45567; 45631; 45654; 45663; 11048; 11033; 1010; 31081; 11045; 11046; 11072; 11036; 72407; 72453; 72455; 72460; 72461; 72466; 72475; 72477; 72501; 72413; 72446; 21073; 21077; 21128; 21131; 21138; 11008. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Ltda.; Siemens Medical Solutions USA, Inc.; Siemens Ltda 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
    1901
  • 날짜
    2016-05-25
  • 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
    Recommendations for users and patients: To correct the variation in mu values, Siemens recommends that you perform the cross-calibration procedure of the scanner. In addition to cross-calibration of the PET scanner relative to the dose calibrator, this procedure will also take into account the different mu values ​​of a solid third-party Germanium-68 quality phantom or liquid to ensure the most accurate quantification in corrected attenuation PET images .
  • 원인
    Siemens healthcare informs that using a different phantom from siemens solid germanium-68 phantom can affect the calibration factor values ​​generated during the pet quality control procedure. depending on the type of uniform phantom used to perform the pet quality control, the pet calibration factor may be biased due to the fact that the system uses a specific mu value of 0.1 cm -1, which is based on the germanium-68 phantom from siemens. the system will use this default mu value regardless of the actual mu value of the phantom used for the pet quality control; this may cause a variation in the quantification of pet images with corrected attenuation.
  • 조치
    Action code MI503 / 16 / S. Letter to affected customers

Device

Commercial Name: PETROLEUM TOMOGRAPHY EQUIPMENT BY PETROLEUM (PET) / COMPUTERIZED TOMOGRAPHY (CT)...

Manufacturer

Siemens Ltda.; Siemens Medical Solutions USA, Inc.; Siemens Ltda