Class 2 Device Recall Merge Cardio

• Date Initiated by Firm: February 19, 2025
• Date Posted: March 20, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1402-2025
• Recall Event ID: 96344
• 510(K)Number: K192206
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
• Code Information: Lot Code: Software versions and UDIs 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206 12.1, UDI: (01)00842000100928(10)12.1(11)210122; 12.1.1, UDI: (01)00842000100928(10)12.1.1(11)211220; 12.2 UDI: (01)00842000100065(10)12.2.0(11)220713; 12.3, UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.1 UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.2 UDI: (01)00842000101109(10)12.3.2(11)230612; 12.3.3 UDI: (01)00842000101109(10)12.3.3(11)230913; 12.4 UDI: (01)00842000101123(10)12.4.0(11)231220; 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522; 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206
• Recalling Firm/ Manufacturer: Merge Healthcare, Inc.; 900 Walnut Ridge Dr; Hartland WI 53029-8347
• For Additional Information Contact: Nadia Marchant; +1-262-3670700
• Manufacturer Reason for Recall: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
• FDA Determined Cause: Software design
• Action: Merge Healthcare issued an Urgent Field Safety Notice to it's consignees on 02/19/2025 via email. The notice explained the issue, risk to patients, provided a workaround to immediately address the issue, and recommended clinicians check measurements in the final report to ensure that they accurately reflect the patient's condition pending software update. Required Actions: Merge Healthcare Support will contact all customers to: i) Confirm that you have read and understood this Urgent Field Safety Notice. ii) Schedule an update to implement the configuration change on your system. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge. Please forward this notice to any individuals within your organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The firm identified a missing software version (11.0.2) and issued the corrected notice on 03/03/2025.
• Quantity in Commerce: 253
• Distribution: US
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = LLZ