Recall Z-2647-2023 ยท DQK Computer, Diagnostic, Programmable
Baxter Healthcare Corporation
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
| Date | Sep 28, 2023 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052883 | CARDIOSERVER Datrix, Nov 1, 2005 |