28

Sep

2023

FDA Recall: Caliper Tool Has Become Non-Responsive

0

Company: Baxter Healthcare Corp.
Date of Enforcement Report: 09/28/2023
Class II

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.

Recall Number:

Z-2647-2023

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Baxter Healthcare Corporation

VOLUME OF PRODUCT IN COMMERCE:

89 units

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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