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Merge Healthcare, Inc.: Merge PACS, medical imaging diagnostic workstation

Medical DevicesSource: FDA (device) · Date: 2026-08-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Merge Healthcare, Inc.
Product
Merge PACS, medical imaging diagnostic workstation
Reason / hazard
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Recall initiated
2026-06-30
Code info
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.
Product quantity
53 units
Voluntary mandated
Voluntary: Firm initiated
City
Hartland
State
WI
Country
United States
Event id
99391
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