DATE NOTIFICATION INITIATED:
April 6, 2018
PRODUCT / LOT NUMBER:
Affected Products: DXT Relay 2.X (5S9800, 5S9801, 5S9802, 5S9803)
Lake Zurich, IL
Fresenius Kabi USA has initiated a mandatory software update Field Action of the DXT Relay 2.x because of issues identified in the software that cause the software to operate other than expected. The issues are found in all versions of DXT Relay 2.x. The issues impact the ability of procedure data to be transmitted from a collection device to the customer's electronic data management system, (Collection devices include Amicus, Aurora, and Alyx devices). Procedure data remains intact on the collection device when an issue occurs. DXT Relay 1.x is not impacted due to software architecture differences and feature set functionality.
The changes being made fix system issues and restore the device back to the specifications of the previously cleared DXT Relay software application. Customers will be contacted by a Fresenius Kabi service representative to schedule a service appointment for updating the software.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.