Merge PACS and Merge OrthoPACS recall (Merge Healthcare, Inc.)
Medical deviceClass IIOngoing
Summary: Merge Healthcare, Inc. is recalling Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation. Reason: Software issue may cause measurements to be displayed inaccurately.
What is being recalled
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Why
Software issue may cause measurements to be displayed inaccurately.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington. (states named: California, Florida, Kentucky, Nebraska, Washington)
How to tell if yours is affected
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3004-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 22, 2026 |
| Reported | September 2, 2026 |
| Company | Merge Healthcare, Inc. |
| Company location | Hartland, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20 units |
More recalls from Merge Healthcare, Inc. · all medical device recalls · recalls from July 2026