BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1245-2017 · Initiated December 22, 2016

    Recall

    Recall Number
    Z-1245-2017
    Event Number
    76173
    Firm
    Tosoh Smd Inc
    FEI Number
    3005529799
    Product Code
    PQQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 22, 2016
    Terminated
    June 18, 2019
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    Description

    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.

    Reason

    Power outages causes reporting software to shutdown.

    Action

    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.

    Distribution

    US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.

    Quantity

    34