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Open, Classified

Merge PACS, medical imaging diagnostic workstation

FDA Recall Z-2874-2026 · Posted 2026-08-04

Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2026-06-30
Product Quantity53 units

Reason for Recall

Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

Firm Action

Merge Healthcare issued an Urgent Field Safety Notice (Revision 2) to its consignees on 6/30/2026 via email. The notice explained the issue and when it may occur, risk to patient, and requested an immediate workaround, a configuration change, be performed to disable automatic refresh of the Thumbnail Bar until a software update is available. The notice also directions the consignee to forward the notice to any individuals within their organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The notice was followed by telephone calls beginning on 7/6/2026 to ensure the notice was received. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge.

Root Cause

Software Design Change

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, and UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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