Merge PACS recallZ-2875-2026 · Merge Healthcare, Inc. · initiated Jun 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software Design Change
What the company is doing
Merge 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.
Recall details
- Recall number
- Z-2875-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2026
- Posted by the FDA
- Aug 4, 2026
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 5 units
- Product code
- LLZ
- FDA submissions
- K192455
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Product description
Merge OrthoPACS, medical imaging diagnostic workstation
Code information (models, lots, serial numbers)
UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Merge PACS 9.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls1 report
Product lines
Other devices under the same FDA submission
3 devices cleared under K192455 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Merge PACS 8.1Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall3 reports
- Merge PACS 9.5Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall1 report
- Merge PACS 9.4Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99391).
- Z-2874-2026 · Open, ClassifiedMerge PACS, medical imaging diagnostic workstation
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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