Events

Alerta De Seguridad para ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. Serial numbers: 400294.

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 S.A; 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
    1845
  • Fecha
    2016-04-01
  • 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
    Alignment failure can result in system blocking, causing an interruption of the procedure in progress. However, the company stresses that this problem does not influence the treatment of patients.
  • Causa
    Siemens healthcare diagnostics sa informs that the field action us028 / 15 / s deals with a bevel alignment problem on the front panel, the plastic cover around the transducer ports prevents complete contact of the connector in the transducer to the port of the transducer. transducer in the system, resulting in system blocking.
  • Acción
    The field action code US028 / 15 / S initiated by Siemens deals with a correction in the field, correction of parts and pieces, by means of previous sending of letter to the client, with risk classification III (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences). Recommendation to users and patients: 1. In the case of a transesophageal transducer that has been inserted in a patient, we recommend the user first disconnect and reconnect the transducer. 2. If the system remains locked, the user must follow the on-screen instructions and disconnect the transducer, remove it from the patient and contact a Siemens service representative.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. S...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA Inc
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA