Retiro De Equipo (Recall) de Device Recall CellaVision DM96, DM1200, DM9600 and DI60

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cellavision AB.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    80137
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2184-2018
  • Fecha de inicio del evento
    2017-12-04
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Device, automated cell-locating - Product Code JOY
  • Causa
    A software malfunction was found where wbc, rbc and plt comments added after a slide is signed, are not sent to the lis. this can only occur where customers process multiple slides per blood sample.
  • Acción
    CellaVision sent an Urgent Medical Device Recall letter dated December 4, 2017. The letter identified affected product, problem and the actions to be taken. Customers are requested to determine if they are affected or not. If affected they are requested to contact their local distributor for installing a patch. Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to their local distributor. For technical questions contact CelleVision (service@cellavision.se)

Device

  • Modelo / Serial
    Versions 6.0.1 or 6.0.2
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of FL, IL, NY, and NC
  • Descripción del producto
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 || Product Usage: || The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Cellavision AB, Forskningsbyn Ideon, Scheelevagen 19a, Lund Sweden
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA