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.
Check against the official notice below — it lists the full affected range.
Fresenius Medical Care is recalling 2008T and 2008T Bluestar hemodialysis machines with CDX used in healthcare facilities for acute and chronic dialysis therapy. The machines have a software and hardware issue that makes the UI-MICs Board sensitive to electromagnetic interference, which triggers a false alarm message reading "Remove USB 2 Device." A total of 70,552 units of the 2008T with CDX and 25,205 units of the 2008T Bluestar with CDX have been distributed nationwide. The issue affects software versions 2.72 and earlier.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
(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".
Reason for recall: (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". Distribution: US Nationwide distribution. Quantity: 2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205 Lot/code info: Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.