FDAAugust 10, 2023device
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
008609910003550086099100036200860991000379
Recall history
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