Events

Alerta De Seguridad para Technical Name: Linear Accelerator ANVISA Registration Number: 10234230125/10234230172/10234230073 Hazard Class: III Model Affected: Acceptable MD4 Serial numbers affected: 3221; 3229; 3554; 3585; 3589; 3655; 3787; 3857; 3889; 3903; 3911; 3913; 3927; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 70-4118; 70-4203; 3598; 3752; 5508; 5509; 5526; 5287; 5529; 5386; 5746; 5828; 5867

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 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
    2220
  • Fecha
    2017-02-24
  • 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
    It is recommended to include the Safety Note in the System Owner's Manual.
  • Causa
    Siemens healthcare diagnostics reports that incorrect values ​​for the position of the rotational collimator are displayed. this may occur if the slider, on which the sensors used to detect the position of the rotational collimator are mounted, is not fully engaged. to keep the sensor slider in place, a locking plate must be mounted on the sensor slider. this will significantly reduce the risk of the sensor slider mechanically misalign and display incorrect values ​​for the position of the rotational collimator.
  • Acción
    Field Action Code TH008 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Technical Name: Linear Accelerator ANVISA Registration Number: 10234230125/10234230172/1023423007...

Manufacturer

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