Events

Alerta De Seguridad para LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 5746; 5828

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 AG; Siemens Medical Solutions USA, Inc..

¿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
    1691
  • Fecha
    2015-09-19
  • 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
    Simens Ltda informs that this field action aims to implement (software update) all necessary corrections previously already identified by other field actions (communications to clients). As previously reported in other releases to customers, the equipment could continue to be used until a new software version was released to correct / improve these issues.
  • Causa
    Siemens announces that the syngo rt therapisttm software version and the control console software have been updated to address the following safety issues: - automatic movement prevention in the event of a significant risk of collision; - repositioning of 160 mlc after the motion stop block; - restarting the command console; - support of fractional monitor units for virtual wedge; - loss of information after the change of the uid of the plan in the information system on cancer (ois); - calculation of incorrect automatic deviation in combination with images acquired with ctvision; - calculation of incorrect deviation in the adaptive targeting option; - interruption of the reconstruction of the cone beam; - table rotation values ​​for relative setup; - resumes during the wrong session in the case of 0 (zero) managed monitor units; - unintended movement of the table after the internal error message in the syngo rt therapist; - dose linearity quality control procedure for the imrt (physics primer user documentation update); - automatic sequence setup for bolus fields; - workflow information to change the patient for treatment from one digital linear accelerator to another. the corrective measures described in this field safety information affect the syngo rt therapisttm combination and the control console. both upgrades must be performed at the same time to ensure proper system operation.
  • Acción
    The company guides the custody of the Portuguese Charter of this field action together with the Owner's Manual of the Linear Accelerator System for any queries.

Device

LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 5746; 5828

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA