# FDA recall Z-0734-2023

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2022-07-27.

## 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

## 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.

## Key facts

- **Recall number:** Z-0734-2023
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-27
- **Report date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0734-2023

## Citation

> AI Analytics. FDA recall Z-0734-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0734-2023. Source: US FDA. Licensed CC0.

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