Z-3004-2026Class II

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Name: Z-3004-2026 Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Creator: Merge Healthcare, Inc.
Published: 2026-07-22
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2026-07-22 / Open, Classified / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation on 2026-07-22. FDA classified it as Class II and gives the reason as "Software issue may cause measurements to be displayed inaccurately". 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-3004-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-22
Posted: 2026-08-21
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software issue may cause measurements to be displayed inaccurately.
Root cause tag: software
FDA root cause: Software Design Change
Action: Merge Healthcare issued an Urgent Field Safety Notice to its consignees on 7/22/2026 via email with a follow-up telephone call. The notice explained the issue and how to identify it, risk to patient, and requested the following: "Immediate actions to reduce risk to patients Merge Healthcare recommends that customers contact Merge Healthcare Support to identify any affected ultrasound studies and the necessary next steps to be taken. Until the software update is installed, ultrasound measurements performed using the Merge PACS & OrthoPACS Viewer should be confirmed against the measurements acquired at the ultrasound modality." The required actions are as follows: "Merge Healthcare Support will contact all customers to: i) Confirm that you have read and understood this Urgent Field Safety Notice. ii) Assist you in identifying and reviewing any ultrasound studies with measurements that may have been affected. iii) Schedule the installation of the software update that eliminates the root cause of this issue. Please forward this notice to any individuals within the 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. 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: 20 units
Distribution: US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Product codes and lots: Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3004-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3004-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)