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Home › FDA recalls › Merge PACS and Merge OrthoPACS
CLASS II · ModerateFDA

Merge Healthcare, Inc. recalls Merge PACS and Merge OrthoPACS

📅 Jul 22, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Jul 22, 2026
Reported
Sep 2, 2026
Distribution
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Status
Ongoing
Quantity
20 units
Lot / codes
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Company location
Hartland, WI
Recall type
Voluntary: Firm initiated
Recall number
Z-3004-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3004-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.