Baxter Epiphany Cardio Server E3 ECG Management System… recallZ-2647-2023 · Baxter Healthcare Corporation · initiated Aug 10, 2023
Class II Open, Classified All recalls posted in September 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Baxter Healthcare initially notified consignees via email on 08/10/2023 of the issue and that a software patch would be implemented. An additional notification was sent to consignees via first-class mail on 08/30/2023. Consignees were instructed that Cardio Server support representatives will contact each facility to arrange for the installation of the software patch or consignees can proactively reach out to the Cardio Server Support team to schedule the patch update. Operators may continue to use the Cardio Server ECG Management System caliper tool prior to the installation of the software patch by following the steps listed in the notification letter. Customers were also instructed to notify other facilities or departments if the affected units have been further distributed, and to acknowledge receipt of the notification by responding on Baxter's portal at the website included in the letter.
Recall details
- Recall number
- Z-2647-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2023
- Posted by the FDA
- Sep 28, 2023
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 89 units
- Product code
- DQK
- FDA submissions
- K052883
- 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.
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cardio Server 6.1Epiphany Healthcare Data Management, LLC · Computer, Diagnostic, Programmable1 recall0 reports
- Cardio Server 6.2Epiphany Healthcare Data Management, LLC · Computer, Diagnostic, Programmable1 recall0 reports
- Cardio Server 7.0Epiphany Healthcare Data Management, LLC · Computer, Diagnostic, Programmable1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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