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Merge PACS, medical imaging diagnostic workstation

Class II
Recalling firm
Merge Healthcare, Inc.
Reason for recall
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Affected products (lot / model / serial)
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.
Units affected
53 units
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Firm location
Hartland, WI, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-2874-2026
Recall initiated
June 30, 2026
FDA classification date
August 4, 2026
FDA report date
August 12, 2026
FDA event ID
99391
Last updated on HTM Vibe
August 18, 2026
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