Recall Z-1402-2025 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
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.
| Date | Mar 20, 2025 (initiated Feb 19, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 mo |
| Quantity | 253 |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192206 | 32mm Glenosphere and Humeral Cup Fx Shoulder USA, Inc., Oct 8, 2019 |