FDA Reports Class II Recall of Merge PACS and Merge OrthoPACS Software on September 2, 2026
On September 2, 2026, the FDA reported a Class II recall of Merge PACS and Merge OrthoPACS software due to a measurement display issue.
2 reports on this incident · first at Sep 7, 2026, 8:52 p.m. ET
Earlier reports
Sep 7, 2026, 8:52 p.m. ETFirst report
FDA Class II Recall Issued for Merge PACS and Merge OrthoPACS Software
The U.S. Food and Drug Administration (FDA) issued a Class II recall on September 2, 2026, for Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation software manufactured by Merge Healthcare, Inc. of Hartland, Wisconsin. The recall, identified as Z-3004-2026, was initiated on July 22, 2026, and affects 20 units distributed nationwide in California, Florida, Kentucky, Nebraska, and Washington.
The recall was prompted by a software issue that may cause measurements to be displayed inaccurately. According to the FDA enforcement report, the affected software version is V9.5, identified by UDI (01)00842000101239(10)9.5.0(11)260409. The recall status is listed as ongoing.
The FDA classifies this as a Class II recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The FDA's enforcement database records no other enforcement actions by Merge Healthcare, Inc. The cause of the software issue has not been determined.
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Revision history
- Version 18 Sept 2026, 00:52current
First published.
- Version 18 Sept 2026, 00:53current
First published.
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