Alerta De Seguridad para Trade name: Somatom Emotion computed tomography equipment. Technical name: CT Scanner. ANVISA registration number: 10345161972. Risk class: III. Model affected: SOMATOM Emotion 16 (2007); SOMATOM Emotion 16 Slice (BR); SOMATOM Emotion 6 (2007); SOMATOM Emotion 6 Slice (BR). Affected serial numbers: See "List of Series Under Risk" annex. . Trade name: CT Scanner Somatom Spirit Brand Siemens. Technical name: CT Scanner. ANVISA registration number: 10345162002. Class of risk: III. Model affected: SOMATOM Spirit (BR); SOMATOM Spirit; SOMATOM Spirit Power; SOMATOM Spirit Power (BR). Affected serial numbers: See "List of Series Under Risk" annex. . Trade name: Somatom Scope Power CT Scanner. Technical name: CT Scanner. ANVISA registration number: 10345161975. Class of risk: III. Model affected: SOMATOM Scope (BR); SOMATOM Scope Power (BR); SOMATOM Scope. Affected serial numbers: See "List of Series Under Risk" annex. . Trade name: CT Scanner Somatom Perspective. Technical name: CT Scanner. ANVISA registration number: 10345162001. Risk class: III. Affected Model: SOMATOM Perspective 64/128 (BR); SOMATOM Perspective. Affected serial numbers: See annex "Series List Under Risk"

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

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 the problem described will not occur when using a lateral topograph instead of a topographer pa or ap. Consequently, the company recommends the use of topograms in lateral position for all head acquisitions. Also, considering that the pa or ap topogram is preferred in specific protocols such as CarotidAngio and RT_HeadNeckShouder acquisitions, the company recommends that the operator disable the Dose4D CARE function for this type of acquisition. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 08/03/2018 - Date of notification notice to Anvisa: 04/06/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Siemens has identified possible incorrect amphole current calculations by the care dose4d algorithm when used in topographic tomography based on topograms pa (posterior-anterior) or ap, which may result in mis-calculated dose distribution and consequent unnecessary exposure to radiation.
  • Acción
    Field Action Code CT003 / 18 / S triggered under the responsibility of Siemens Healthcare Diagnósticos Ltda. Field correction. Due to the possibility reported, the software update will be performed to correct the problem.


  • Empresa matriz del fabricante (2017)
  • Source