Merge PACS, medical imaging diagnostic workstation

FDA device recall Z-2874-2026 · posted 2026-08-04 · Open, Classified

Recall details

Recalling firm

Merge Healthcare, Inc.

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.

Action taken

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

Status

Open, Classified

Product code

LLZ

Quantity affected

53 units

Distribution

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

Date initiated

2026-06-30

Date posted

2026-08-04

Location

Hartland, WI

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