Recall- Software Upgrade Causes Increased Sensitivity to EMI Leading to False Alarms

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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