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U.S. Department of Health and Human Services

Class 2 Device Recall Merge OrthoPACS

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 Class 2 Device Recall Merge OrthoPACSsee related information
Date Initiated by FirmJune 30, 2026
Date PostedAugust 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2875-2026
Recall Event ID 99391
510(K)NumberK192455 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMerge OrthoPACS, medical imaging diagnostic workstation
Code Information UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
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		Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
FDA Determined
Cause 2		Software Design Change
ActionMerge Healthcare issued an Urgent Field Safety Notice (Revision 2) to its consignees on 6/30/2026 via email. The notice explained the issue and when it may occur, risk to patient, and requested an immediate workaround, a configuration change, be performed to disable automatic refresh of the Thumbnail Bar until a software update is available. The notice also directions the consignee to forward the notice to any individuals within their 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 notice was followed by telephone calls beginning on 7/6/2026 to ensure the notice was received. 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 Commerce5 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, and UK.
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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