FDAHealthJune 30, 2026
Merge Healthcare, Inc. — Merge OrthoPACS, medical imaging diagnostic workstation
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Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 30, 2026
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
What's affected?
- Product
- Merge OrthoPACS, medical imaging diagnostic workstation
- Lot code
- UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
Additional details
UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5 units.
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