Z-2063-2019Class II

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Name: Z-2063-2019 Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Creator: Merge Healthcare, Inc.
Published: 2019-07-11
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2019-07-11 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 on 2019-07-11. FDA classified it as Class II and gives the reason as "Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2063-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-11
Posted: 2019-07-23
Terminated: 2023-03-17
Recalling firm: Merge Healthcare Incorporated
Product: Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Root cause tag: software
FDA root cause: Software Design Change
Action: Merge Healthcare notified customers on about 07/11/2019 via "Urgent Field Safety Notice" letter. The notice informed customers of two possible issues that may occur on Merge PACS and Merge OrthoPACS: 1. Prior thumbnails may not display in reverse chronological order. 2. Images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Use of an out of order image may result in the implementation of an incorrect or unnecessary treatment plan such as unnecessary medication, change in dosage of existing medication, or unnecessary medical procedures. It may also lead to progression of an existing patient condition, which may result in the progression of a disease state. Merge Healthcare will provide a software correction for the issue. A Merge Healthcare representative will contact each customer schedule the correction. In the interim, Merge Healthcare instructed customers that they can continue to use their Merge PACS/OrthoPACS devices by following the below instructions: 1. When pulling a series from thumbnail bar, confirm that the date of each series is visible in the viewport. The date will appear when overlays are configured to display the date. An administrator can assist in configuring Merge PACS/OrthoPACS if needed. 2. When utilizing the mammography scroll stacking tool, confirm that the date of each series is visible in the viewport. The date will appear when overlays are configured to display the date. An administrator can assist in configuring Merge PACS/OrthoPACS if needed. Customers were instructed to use the date, rather than the order the series are presented in, to determine chronological order. Additional instructions included to ensure all potential users of Merge PACS and Merge OrthoPACS have received this notice. Questions regarding the recall notice can be directed to Merge Customer Support at 877-741-5369.
Quantity in commerce: 73 devices
Distribution: Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
Product codes and lots: Version 7.3 (UDI Number (01)00842000100706(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100706(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01)00842000100775(10)8.0.0.162051(11)181026); 8.0.1 (UDI Number (01)00842000100775(10)8.0.1.165704(11)190528)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2063-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2062-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2063-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23

Product code LLZ

K173475Class IIMerge PACSMerge Healthcare Incorporated / cleared 2017-12-08

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)