Notice names this product. Merge Healthcare’s Merge PACS and Merge OrthoPACS is named in FDA Class II recall Z-3004-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Software issue may cause measurements to be displayed inaccurately. Identifying details: Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409. Units affected: 20 units. Status: Ongoing.
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.
Merge PACS and 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.
Software issue may cause measurements to be displayed inaccurately.
Company / brand: Merge Healthcare recalls
Affected product: Merge PACS and Merge OrthoPACS recall status
Official ID Z-3004-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.