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Recall Observatory FDA recall evidence

Device product

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.

Z-1245-2017

December 22, 2016

Class II

Product summary

Firm
Tosoh Smd Inc
Event
Event 76173
Status
Terminated
Classification
Class II
Quantity
34
Official record key
device-enforcement:Z-1245-2017

Official wording

Reason: Power outages causes reporting software to shutdown.

Code information: All G8's with Reporting Software interfaced with LIS.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Power outages causes reporting software to shutdown.

Field note

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