Events

Alerta De Seguridad para Laboratory Information Systems with Microbiology Modules: (1) Version 5.23, (2) Version 5.3

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Sunquest Information Systems 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
    344
  • Fecha
    2001-11-23
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    A defect reported in the above information systems may cause lab test results to be printed incorrectly. the manufacturer initiated the correction by product safety note numbers psn-01-l08 and cn-01-07 dated march 23 and april 16, 2001 respectively.
  • Acción
    Please verify receipt of Product Safety Note numbers PSN-01-L08 and CN-01-07 dated March 23 and April 16, 2001, respectively, submitted by Sunquest Information Systems. If the product is being used, follow the temporary procedures set out in the above-described Product Safety Note number CN-01-07, submitted by Sunquest Information Systems. Product repair can be obtained by contacting Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact your local representative or Sunquest Information Systems at 1 (520) 382-6170 in the United States. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Laboratory Information Systems with Microbiology Modules: (1) Version 5.23, (2) Version 5.3

Manufacturer

Sunquest Information Systems Inc
  • Source
    ANVSANVISA