# FDA recall Z-1748-2020

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2020-03-12.

## Product

Fresenius 2008T Hemodialysis Machine:  Part Number Description  190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS;  190713 2008T HEMODIAL YSIS SYS., with CDX;  190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG;  190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX;  190895 2008T GEN 2 BIBAG WITHOUT CDX;  190908 2008T HD System With CDX, CAN

## Reason for recall

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

## Distribution

Nationwide  Foreign: Canada, Curaca, Guam

## Key facts

- **Recall number:** Z-1748-2020
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-12
- **Report date:** 2020-04-29

- **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-1748-2020

## Citation

> AI Analytics. FDA recall Z-1748-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1748-2020. Source: US FDA. Licensed CC0.

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