Events

Alerta De Seguridad para Two products are affected by the action of Field: 1. Trade Name: E.CAM SIGNATURE SERIES MARK SIEMENS - Technical Name: Camile Cintilografica (Gamma Camera) - Registration 10234230040 - Model: E.CAM Signature Series, brand SIEMENS /// 2. Trade name: SISTEMA SPECT - Registro 10345161991 - Model: Symbia E - Technical name: Nuclear Imaging System - ANVISA registration number: 80004040126 /// Number of series affected: 3002; 3003; 3006; 4004; 1086; 1093; 1126; 1007; 2016; 3051; 3072; 4019; 4022; 4091; 4102; 4124; 4192; 5017; 5028; 4042; 4091; 7546; 7552; 8671; 8797; 8019; 5626; 7016; 7006; 7507; 550; 588; 3097; 11194; 11463; 10012; 11048; 11073; 9002; 9036; 9029; 1031; ; 1033; 1040; 1047; 1051; 1056; 1066; 1084; 1085; 1050; 1111; 1113; 1115; 1161; 1169; 1241; 1267; 1334; 1358; 1366; 1367; 1368; 1371; 1372; 1157; 1166; 1173; 1194; 1210; 1231; 1259; ; 1267; 1303; 1314; 1318; 1355; 1383; 1391; 1403; 1404; 1406; 1678; 1681; 1682; 1032.

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
    2008
  • Fecha
    2016-10-25
  • 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 instructions for use of the system.
  • Causa
    If the patient is positioned incorrectly and is unaccompanied during the examination, it is possible for their hair to be trapped in the patient bed unit's uphill / descent unit of the e.Cam and symbia e.
  • Acción
    Field Action No. MI009 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company issued a Letter to Customers stating that patient positioning instructions must be respected so that patients' hair is not trapped in the patient's up / down units. patient bed

Device

Two products are affected by the action of Field: 1. Trade Name: E.CAM SIGNATURE SERIES MARK SIEM...

Manufacturer

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