Recall Z-2874-2026

Merge Healthcare, Inc. · initiated June 30, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Merge PACS, medical imaging diagnostic workstation

Codes / lots: 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.

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.

FDA-determined cause: Software Design Change

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.

Details

Recall number
Z-2874-2026
Initiated
June 30, 2026
Posted by FDA
August 4, 2026
Product code
LLZ – System, Image Processing, Radiological
Quantity
53 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Recalling firm
Merge Healthcare, Inc., Hartland, WI

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2875-2026 Class IIMerge OrthoPACS, medical imaging diagnostic workstationMerge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient… 06/30/2026Open, Classified