FDAFDA recall Z-2875-2026 · Aug 12, 2026
Merge Healthcare, Inc.: Merge OrthoPACS recall
Recall found
Product
Merge OrthoPACS, medical imaging diagnostic workstation
Reason for recall
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What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
- Quantity
- 5 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, and UK.
- Recalling firm
- Merge Healthcare, Inc., Hartland, WI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-30
Source: openFDA enforcement record Z-2875-2026 · search recall number Z-2875-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.