Merge PACS recallZ-3004-2026 · Merge Healthcare, Inc. · initiated Jul 22, 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
Software issue may cause measurements to be displayed inaccurately.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-3004-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 22, 2026
- Posted by the FDA
- Aug 21, 2026
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 20 units
- Product code
- LLZ
- FDA submissions
- K192455
- Distribution
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Product description
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Code information (models, lots, serial numbers)
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Merge PACS 9.5Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall1 report
Product lines
Other devices under the same FDA submission
2 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 9.4Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall0 reports
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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