Epiphany Cardio Server

Epiphany, now a Baxter Healthcare company, is issuing an urgent medical device correction for the Cardio Server E3 ECG Management System Software 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. If this occurs, the calipers will appear on the screen but are not adjustable, and using any of the caliper controls results in no action. This issue does not prevent the user from changing measurement values before confirming a study. A software patch has been released to address this issue and our cardio server support team will contact you soon to arrange for installation. This issue does not affect the classic cardio server user interface.

Recall Start Date: August 31, 2023