Z-2647-2023Class II

Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x...

Name: Z-2647-2023 Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x...
Creator: Baxter Healthcare Corporation
Published: 2023-08-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-08-10 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x on 2023-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2647-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-09-28
Recalling firm: Baxter Healthcare Corporation
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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2647-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2647-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-28

Product code DQK

K052883Class IICardioserverDatrix / cleared 2005-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)