Reported Oct 4, 2023 · Ongoing
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Baxter Epiphany Cardio Server E3 ECG Management
- System Servers with software versions
a) v6.1.xb) v6.2.xc) v7.0.x
- Lot codes and dates
a) v6.1.xUDI/DI 00860991000355all serial numbersb) v6.2.xUDI/DI 00860991000362all serial numbersc) v7.0.xUDI/DI 00860991000379all serial numbers
- Amount recalled
- 89 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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