# FDA recall Z-2647-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-08-10.

## Product

Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions:  a) v6.1.x, b) v6.2.x, c) v7.0.x.

## Reason for recall

Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AL, AR, AZ, CA, CA, CT, FL, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MO, MS, MT, NE, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Canada and Bermuda.

## Key facts

- **Recall number:** Z-2647-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-10
- **Report date:** 2023-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2647-2023

## Citation

> AI Analytics. FDA recall Z-2647-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2647-2023. Source: US FDA. Licensed CC0.

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