Events

Alerta De Seguridad para Affected Products: VITROS 5600 INTEGRATED SYSTEM. Anvisa Registers: 80145901205. Hazard Class: I. Products Affected: All VITROS® 5600 Diagnostic Systems. List of Potentially Affected Products Distributed in Brazil (SEE ANNEX, link. .anvisa.gov.br / wps / wcm / connect / a11b19004c360fd7a008f81cd37d2b72 / Distributed% + integrated system + vitros + 5600.pdf? MOD = AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. Prod. Para Saúde Ltda.; Ortho Clinical 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
    1841
  • Fecha
    2016-03-16
  • 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
    Recommendation to Users and Patients: An Ortho trained service representative will contact you to schedule an inspection of the Vitros 560 system wiring at your facility. If appropriate, the wiring will be reconfigured.
  • Causa
    This notification provides information about the potential that four wires connected to the power supply have been misconfigured on your vitros® 5600 system (s) during manufacturing. if a system has an incorrect wire configuration, it is possible that the power for a given module, which must be turned off, will remain on. however, there will be no risk for ortho's trained service personnel if they follow normal procedures and turn off the appropriate module or the vitros ® 5600 system as a whole before working on a component.
  • Acción
    Action code 16000017. Communication to customers who received affected units /// Field correction of parts and parts.

Device

Affected Products: VITROS 5600 INTEGRATED SYSTEM. Anvisa Registers: 80145901205. Hazard Class: I....

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. Prod. Para Saúde Ltda.; Ortho Clinical Diagnostics Inc.