Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Recall Z-3004-2026 · Posted 2026-08-21
Recalling FirmMerge Healthcare, Inc.
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2026-07-22
Product Quantity20 units
Reason for Recall
Software issue may cause measurements to be displayed inaccurately.
Firm Action
Merge Healthcare issued an Urgent Field Safety Notice to its consignees on 7/22/2026 via email with a follow-up telephone call. The notice explained the issue and how to identify it, risk to patient, and requested the following:
"Immediate actions to reduce risk to patients
Merge Healthcare recommends that customers contact Merge Healthcare Support to identify any affected ultrasound studies and the necessary next steps to be taken.
Until the software update is installed, ultrasound measurements performed using the Merge PACS & OrthoPACS Viewer should be confirmed against the measurements acquired at the ultrasound modality."
The required actions are as follows:
"Merge Healthcare Support will contact all customers to:
i) Confirm that you have read and understood this Urgent Field Safety Notice.
ii) Assist you in identifying and reviewing any ultrasound studies with measurements that may have been affected.
iii) Schedule the installation of the software update that eliminates the root cause of this issue.
Please forward this notice to any individuals within the 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.
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.
Root Cause
Software Design Change
Distribution Pattern
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.