Baxter Healthcare Corporation: Medical Device Recall in 2023 - (Recall #: Z-2647-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 10, 2023

Date Posted: October 4, 2023

Recall Number: Z-2647-2023

Event ID: 92940

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.

Status: Ongoing

Product Quantity: 89 units

Code Information:

a) v6.1.x, UDI/DI 00860991000355, all serial numbers, b) v6.2.x, UDI/DI 00860991000362, all serial numbers, c) v7.0.x, UDI/DI 00860991000379, all serial numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated