# FDA recall Z-3124-2024

> **Fresenius Medical Care Holdings, Inc.** · Class II · device recall initiated 2024-08-08.

## Product

Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130

## Reason for recall

Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

## Distribution

US Nationwide. Canada.

## Key facts

- **Recall number:** Z-3124-2024
- **Recalling firm:** Fresenius Medical Care Holdings, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-08
- **Report date:** 2024-09-18

- **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-3124-2024

## Citation

> AI Analytics. FDA recall Z-3124-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3124-2024. Source: US FDA. Licensed CC0.

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