Events

Notificaciones De Seguridad De Campo acerca de Cobas

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Hitachi High Technologies Corporation.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-03-02
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    We regret to inform you that in very rare cases a disturbance of the sample liquid level detection (lld) may occur due to a fretting corrosion on the sample probe connector due to a production change for the connector. in those very rare cases where the disturbance of the sample liquid level detection (lld) occurs, the affected sample probe may dip into the sample material deeper than intended, accordingly the affected sample probe may be not washed adequately (this may lead to carryover, medical risk cannot be excluded). since the beginning of 2017, the affected sample probe connector type has been changed in production to a new connector type. with that new connector type the sample liquid level detection (lld) is ensured to fully function as specified. the potentially affected sample probes will be exchanged free of charge. .

Device

Cobas
  • Modelo / Serial
    cobas c 311 analyzer (cat. no. 04826876001) cobas c 501 module (cat. no. 04745914001) cobas c 502 module (cat. no. 05964067001) cobas c 701 module (cat. no. 05641489001) cobas c 702 module (cat. no. 06473245001) cobas 8000 ISE module 900 (cat. no. 05641497001) cobas 8000 ISE module 1800 (cat. no. 05964075001)
  • Manufacturer
    Hitachi High Technologies Corporation

Manufacturer

Hitachi High Technologies Corporation
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    AMPMDRS