Notice names this product. Merge Healthcare’s Merge OrthoPACS is named in FDA Class II recall Z-2875-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. Identifying details: UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.. Units affected: 5 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Merge OrthoPACS
Company / brand
Merge Healthcare
Lot / serial / date codes
UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Agency product description and boundaries
Merge OrthoPACS, medical imaging diagnostic workstation
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.