Events

Alerta De Seguridad para AXIOM ICONOS X-ray System Technical Name: X-Ray Fluoroscopic System ANVISA Registration Number: 10234230063 Hazard Class: III Affected Model: R100, R200 Serial Numbers Affected: 4603, 10021, 10024, 10025, 10026, 10034, 10039, 10039, 10019, 10243, 10244, 11000, 11003, 11018, 11101, 11113, 12005, 12018, 12111, 12132, 12133, 12192, 12194, 12123, 12223, 12401, 12403, 12405, 12406

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 SHANGHAI MEDICAL EQUIPMENT LTD..

¿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
    2264
  • Fecha
    2017-04-20
  • 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
    The user must avoid any collision of the table with objects in the operating area of ​​the table. In the event of a collision, it is mandatory to carry out a preventive inspection by the SIEMENS Technical Assistance Service which should be contacted immediately if a collision of this type occurs. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    Siemens healthcare diagnostics has identified a potential malfunction of the equipment in the event of an accident such as a collision of the table, resulting in risk to patients and employees with systems icons r20 icons c20, r200 icons t20, r100 icons, md icons, rhd icons, rf luminos classic, luminos fusion or luminos select. this malfunction is possible in cases where the vertical tilt movement of the table is obstructed by a solid object (eg a patient stool or ladder), resulting in a collision.
  • Acción
    Field Action Code XP063 / 12 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

AXIOM ICONOS X-ray System Technical Name: X-Ray Fluoroscopic System ANVISA Registration Number: 1...

Manufacturer

Siemens Healthcare Diagnósticos S.A; SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA