Retiro De Equipo (Recall) de Device Recall Keyspan Adapter

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 Tosoh Smd Inc.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fuente del evento
  • 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
    Data acquisition software - Product Code PQQ
  • Causa
    Power outages causes reporting software to shutdown.
  • Acción
    Tosoh Bioscience sent a Customer Recall Notification letter dated December 21, 2016 to customers. The letter identified the affected product, problem and action to be taken. For questions call Tosoh Technical Support at 800-248-6764.


  • Modelo / Serial
    All G8's with Reporting Software interfaced with LIS.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.
  • Descripción del producto
    Keyspan High-High Speed USB to Serial Adapter || Product Usage: || The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.
  • Manufacturer


  • Dirección del fabricante
    Tosoh Smd Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Empresa matriz del fabricante (2017)
  • Source