Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Summary
The FDA issued a Class II for Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ver by Baxter Healthcare Corporation. Reason: Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software list.
Details
Source
Device Recall
External ID
Z-2647-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
Product Description
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Lot/Code Info: a) v6.1.x, UDI/DI 00860991000355, all serial numbers, b) v6.2.x, UDI/DI 00860991000362, all serial numbers, c) v7.0.x, UDI/DI 00860991000379, all serial numbers
Quantity Affected: 89 units
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AL, AR, AZ, CA, CA, CT, FL, 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 and the countries of Canada and Bermuda.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2647-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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