Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026

Merge PACS, medical imaging diagnostic workstation

Merge Healthcare, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347

Is this the product you have?

  • Merge PACS, medical imaging diagnostic workstation
Lot codes and dates
  • UDI (01)00842000101215(10)9.4.0.P01(11)250916, (01)00842000101154(10)9.4.0
  • P02(11)260302 with Affected Versions
    • 9.4
    • 9.4 P01
    • and 9.4 P02
Amount recalled
53 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Notice updated Aug 10, 2026 · Data as of Sep 19, 5:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.