FDA recall, , Moderate risk
Merge OrthoPACS and PACS
Merge PACS may show thumbnails from a previous patient study while another is open.
Summary by Recall Canary from the FDA notice
What happened
Merge Healthcare, Inc. of Hartland, Wisconsin, began a recall on June 30, 2026, of Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstations, because a potential issue may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. The FDA added the recall to its Enforcement Report on August 4, 2026. The products were distributed nationwide and in Canada and the UK.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Merge OrthoPACS, medical imaging diagnostic workstation
- UDI-DI
- 00842000101154
Merge PACS, medical imaging diagnostic workstation
- UDI-DI
- 00842000101215
- 00842000101154
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
- Company
- Merge Healthcare, Inc.Hartland, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99391
- Recall numbers
- Z-2874-2026 to Z-2875-2026
All recalls from Merge Healthcare, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
