Events

Alerta De Seguridad para COMPUTERIZED TOMOGRAPHY EQUIPMENT SOMATOM EMOTION MARK SIEMENS, Registry No. 10234230121; COMPUTERIZED TOMOGRAPHY EQUIPMENT SOMATOM SPIRIT MARK SIEMENS, Registry No. 10234230116. Distribution_Number of Series of Equipment - See Annex I.

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.

¿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
    1382
  • Fecha
    2014-05-02
  • 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
    The company informs that very rarely the rubber damper can break and cause detachment of the mounting plates in the gantry and can lead to a rupture of the drive belt, and consequently the interruption of image acquisition. In addition, the drive belt can damage the system cover and may invalidate contact protection between moving components inside the gantry and the operator and / or patient.
  • Causa
    The company recently detected the possibility of a premature aging process in a rubber component. the mechanical operation of this rubber damper, which is located in the rotating motor assembly, may degrade over time and impact the stability of the equipment.
  • Acción
    Siemens has prepared a modification for SOMATOM Emotion 6/16, and for SOMATOM Spirit / Spirit Power that will solve this potential breakdown through UI CT030 / 14 / S. The CT030 / 14 / S IU implementation is scheduled for April 2014 and your corrective action instructs our service specialists to replace the rotating motor mounting plate inside the gantry of your CT system by a new model. This new mounting plate includes significantly improved rubber dampers for the stability of your mounting set. The company will schedule customers. See Letter to the Client - Annex II

Device

COMPUTERIZED TOMOGRAPHY EQUIPMENT SOMATOM EMOTION MARK SIEMENS, Registry No. 10234230121; COMPUTE...

Manufacturer

Siemens Ltda
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA