—#202953

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.

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052883
Affected 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

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-08-10
Posted by FDA: 2023-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202953. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.