Merge PACS recall (Merge Healthcare, Inc.)
Medical deviceClass IIOngoing
Summary: Merge Healthcare, Inc. is recalling Merge PACS, medical imaging diagnostic workstation. Reason: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
What is being recalled
Merge PACS, medical imaging diagnostic workstation
Why
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
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
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
How to tell if yours is affected
UDI (01)00842000101215(10)9.4.0.P01(11)250916, (01)00842000101154(10)9.4.0.P02(11)260302 with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
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-2874-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 30, 2026 |
| Reported | August 12, 2026 |
| Company | Merge Healthcare, Inc. |
| Company location | Hartland, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 53 units |
More recalls from Merge Healthcare, Inc. · all medical device recalls · recalls from June 2026