ClearanceBrief
Recall Z-2874-2026 ยท LLZ System, Image Processing, Radiological

Merge Healthcare, Inc.

Merge PACS, medical imaging diagnostic workstation

DateAug 4, 2026 (initiated Jun 30, 2026)
StatusOpen, Classified
ReasonMerge 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.
Root causeSoftware Design Change
ActionMerge 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 S
Quantity53 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, and UK.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K192455Merge PACS
Merge Healthcare Incorporated, Oct 17, 2019