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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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