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Class IIOngoing

Merge Healthcare, Inc. recalls Merge PACS and Merge OrthoPACS

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Merge Healthcare, Inc.
Reason
Software issue may cause measurements to be displayed inaccurately.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99520…

Products

  1. Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

    Codes/lots: Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409Quantity: 20 unitsRecall no. Z-3004-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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