Recall Z-1398-2025

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 taken

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.