Recall Z-1245-2017— Tosoh Smd Inc

Class II FDA medical device recall by Tosoh Smd Inc, initiated 2016-12-22, terminated 2019-06-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Power outages causes reporting software to shutdown..

Recalling firm

Tosoh Smd Inc

Classification

Class II

Status

Terminated

Initiated

2016-12-22

Terminated

2019-06-18

Firm location

Grove City, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.