Baxter recalls Cardio Server E3 ECG Management System servers with specific software versions due to caliper tool becoming non-responsive, potentially affecting patient monitoring.
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.
Baxter is recalling Cardio Server E3 ECG Management System servers with software versions v6.1.x, v6.2.x, and v7.0.x because the caliper tool may become temporarily non-responsive. This could prevent the caliper function from being used during patient monitoring, which is critical for accurate measurements.
The caliper tool in the software may become temporarily non-responsive, preventing its use for measuring patient parameters. This could lead to inaccurate patient monitoring if the tool is needed during critical measurements.
Healthcare providers using the Cardio Server E3 ECG Management System with the specified software versions are most at risk. The recall affects medical devices used in clinical settings for patient monitoring.
Check if your Cardio Server E3 ECG Management System has software versions v6.1.x, v6.2.x, or v7.0.x. The recall includes specific serial numbers and UDI/DI codes for each version.
Identify your Cardio Server E3 software version by checking the device settings or documentation.
The recall is for a temporary non-responsive caliper tool, which may affect patient monitoring but does not pose a risk of serious injury.
Check if your Cardio Server E3 has software versions v6.1.x, v6.2.x, or v7.0.x, and verify the serial numbers or UDI/DI codes listed in the recall notice.
The recall does not specify a remedy, so contact Baxter Healthcare Corporation directly for guidance on next steps.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2647-2023 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2647-2023 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.