Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; Siemens Medical Solutions USA, Inc.; Siemens Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1901
  • Fecha
    2016-05-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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 .
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA