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U.S. Department of Health and Human Services

Class 2 Device Recall Merge PACS and Merge OrthoPACS

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 Class 2 Device Recall Merge PACS and Merge OrthoPACSsee related information
Date Initiated by FirmJuly 22, 2026
Date PostedAugust 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3004-2026
Recall Event ID 99520
510(K)NumberK192455 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Code Information Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
FEI Number 1000116130
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information ContactNadia Marchant
262-367-0700
Manufacturer Reason
for Recall		Software issue may cause measurements to be displayed inaccurately.
FDA Determined
Cause 2		Software Design Change
ActionMerge 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.
Quantity in Commerce20 units
DistributionUS Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
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 = LLZ
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