Events

Alerta De Seguridad para ACUSON Ultrasound Diagnostic System Technical Name: Ultrasound Apparatus ANVISA Registration Number: 10345162017 Hazard Class: II Affected Model: ACUSON S1000, ACUSON S2000, ACUSON S3000 Series Affected Numbers: 201092, 201936, 202290, 202295 , 202352, 202637, 203198, 203217, 203217, 203217, 203217, 203282, 203531, 203535, 203549, 203559, 205259, 205260, 205262, 205282, 205344, 205494, 205521, 205572, 205651, 205701, 205750, 205876, 206270 , 206756, 206984.

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 Healthcare Diagnostics 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
    2090
  • Fecha
    2016-10-24
  • 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
    To avoid the problem of misalignment of the transducers the recommendation is not to use the 6C1 HD and 18L6 HD transducers with the CIVCO biopsy connectors for guided biopsy procedure. Guided procedures should be performed with other transducers as stated in the "Instructions for Use" of the equipment. To avoid the problem of repositioning Virtual Touch IQ, you should not reposition the region of interest of the original location (default).
  • Causa
    The company has identified in acuson s family systems that both the 6c1 hd transducers and the 18l6 hd transducers demonstrate an alignment error when using the screen orientations. this problem occurs when using the civco biopsy connectors in combination with the acuson s family screen orientations. the path of the biopsy needle may not match the orientation of the screen. this occurs on 6c1 hd and 18l6 hd transducers. a possible measurement error on the acuson s family ultrasound system when repositioning the virtual touch iq region of interest from its original (standard) location is also described, the lateral position of the measuring tool may not be in line with the lateral position of the shear velocity data.
  • Acción
    Field Action Code US007 / 16 / S triggered under the responsibility of the company Siemens Ltda. Company will make correction in the field.

Device

ACUSON Ultrasound Diagnostic System Technical Name: Ultrasound Apparatus ANVISA Registration Numb...

Manufacturer

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