Z-0734-2023 Class II Ongoing
FDA device recall Z-0734-2023 was initiated by Fresenius Medical Care Holdings, Inc. on Jul 27, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2022
- Initiation Date
- Jul 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205
Product Description
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
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 Pattern
US Nationwide distribution.
Code Information
Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0734-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026