Merge Healthcare, Inc.: System, Image Processing, Radiological
Recall Summary Merge Healthcare is recalling Merge PACS and Merge OrthoPACS, which are software systems used to display medical images for diagnosis. A software problem can cause measurements shown on these systems to be inaccurate. The recall affects medical facilities across the United States that use these imaging workstations.
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Reason
- Software issue may cause measurements to be displayed inaccurately.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ad241991-a3d3-4464-93dd-bf0c9bfab109