Z-2875-2026Class II

Merge OrthoPACS, medical imaging diagnostic workstation

Name: Z-2875-2026 Merge OrthoPACS, medical imaging diagnostic workstation
Creator: Merge Healthcare, Inc.
Published: 2026-06-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2026-06-30 / Open, Classified / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge OrthoPACS, medical imaging diagnostic workstation on 2026-06-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2875-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-30
Posted: 2026-08-04
Recalling firm: Merge Healthcare Incorporated
Product: Merge OrthoPACS, medical imaging diagnostic workstation
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software Design Change
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.
Quantity in commerce: 5 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Product codes and lots: UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2875-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2874-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04
Z-2875-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04

Product code LLZ

K192455Class IIMerge PACSMerge Healthcare Incorporated / cleared 2019-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)