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FDAFDA · Food and drugs·Recall number Z-2874-2026

Merge PACS, medical imaging diagnostic workstation

Published August 12, 2026 · Recall initiated: June 30, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Merge Healthcare, Inc.
Distributor
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Lot
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.
Risk classification
Class II
Area (FDA)
device
Country
United States

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