The Recall Desk
ModerateFDA (Devices)·Z-2647-2023·Announced 2023-10-04

Baxter Epiphany Cardio Server E3 Caliper Tool Non-Responsive in ECG System

Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The issue is a software malfunction causing temporary loss of function in a clinical tool, identified and corrected proactively.

Plain-English summary

Baxter Healthcare Corporation is recalling the Epiphany Cardio Server E3 ECG Management System with software versions v6.1.x, v6.2.x, and v7.0.x. The caliper tool in the system may become non-responsive, temporarily preventing the caliper function from being used.

The issue was identified in an Urgent Medical Device Correction notice issued by Baxter Healthcare. The problem affects the system's ability to use the caliper tool, which is a measurement and analysis function within the ECG management interface.

Approximately 89 units have been distributed worldwide, including across the United States (AK, AL, AR, AZ, CA, CT, 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), Canada, and Bermuda.

Users of affected systems should contact Baxter Healthcare Corporation for information about the correction and any necessary software updates or workarounds.

The recalled product

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.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Diagnostic Equipment
Hazard
Affected units
89

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

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