Company: Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report:12/20/202
Class II
PRODUCT
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
Recall Number:
Z-0734-2023
REASON
(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”.
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Holdings, Inc.
VOLUME OF PRODUCT IN COMMERCE
2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205
DISTRIBUTION
US Nationwide distribution.
