2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

Fresenius issued Updated Urgent Medical Device Correction REV B Customer Notification letter (Field Action Number: FA-2020-09-W _REV B) to consignees that have CDX equipped machines on 07-27-2022 via USPS First Class Mail. Letter states reason for recall, health risk and action to take: First, a software issue in SW versions 2.72 and earlier. All machines should be updated to current software (SW version 2.74), pursuant to the July 20, 2021, letter. Second, hardware issue that affects only CDX machines. To reduce the chance of EMI causing a false Remove USB Device 2 alarm from occurring we suggest the following: " Insert a USB device in USB Port 2 that will continually draw current. For example, a blank USB memory stick or a USB powered card reader. o NOTE: DO NOT use passive USB devices in USB Port 2 that go into a suspended state drawing minimal/low current which can trip the sensing circuit. An example would be a USB corded optical mouse. Complete/Return the response form enclosed.