Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Epiphany

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Baxter Epiphanysee related information
Date Initiated by FirmAugust 10, 2023
Date PostedSeptember 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2647-2023
Recall Event ID 92940
510(K)NumberK052883 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductBaxter 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 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
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionBaxter 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 Commerce89 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQK
-
-