Events

Alerta De Seguridad para Trade name: E.CAM Signature Series Brand Siemens; SPECT System Technical Name: Camile Cintilografica; Nuclear Imaging System ANVISA registration number: 10234230040; 10345161991 Risk Class: III; II Affected Model: E.CAM Siganture Series, brand SIEMENS; Symbia E, Symbia S Series numbers affected: 3097, 8019, 8011, 5626, 7016, 7507, 7507, 7006, 3072, 2016, 3051, 4019, 4022, 1007, 4102, 5028, 4091, 4124, 4192, 7552, 861, 8797, 7546, 1086, 1126, 1093, 1066, 1033, 1040, 1051, 1031, 1056, 1047, 1084, 3002, 3006, 4004, 3003, 4042, 11194, 11463, 9029, 11048, 9002, 11073, 9036, 1367, 1115, 1161, 1267, 1371, 1241, 1358, 1368, 1050, 1113, 1372, 1366, 1111, 1169.

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. Molecular Imaging..

¿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
    2085
  • Fecha
    2016-11-11
  • 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
    Siemens recommends a re-examination of the "Safety" section of the user manual with the establishment's employees and make sure that this warning is included in the system instructions.
  • Causa
    Siemens healthcare advises that patient positioning instructions must be adhered to so patients' hair is not trapped in the patient bed rise / fall units.
  • Acción
    Field Action Code MI010 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in Field.

Device

Trade name: E.CAM Signature Series Brand Siemens; SPECT System Technical Name: Camile Cintilograf...

Manufacturer

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