Baxter Epiphany Cardio Server E3 ECG Management System recall: Software Issue
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Why was Baxter Epiphany Cardio Server E3 ECG Management System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 89 units
- 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.
- Recall date
- October 4, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)