Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1: Image display issues
Merge Healthcare recalls specific versions of their OrthoPACS software due to potential image display errors when using mammography stacked scrolling features. Affected versions include 7.3, 7.3.1, 8.0, and 8.0.1.
Lower-risk 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).
Contact the company
What happened, in plain English
Merge Healthcare is recalling specific versions of their OrthoPACS medical imaging software. The recall is due to a potential issue where thumbnails might not display in reverse chronological order or images may not scroll properly when mammography stacked scrolling is enabled. This could affect how medical professionals view and compare imaging results. Read more at govinfonow.com/recall/67435-merge-orthopacs-versions-7-3-7-3-1-8-0.
Source Summary by GovInfoNow · govinfonow.com/recall/67435-merge-orthopacs-versions-7-3-7-3-1-8-0 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2063-2019
Cite this page
“Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1: Image display issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67435-merge-orthopacs-versions-7-3-7-3-1-8-0. Based on FDA recall #Z-2063-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2063-2019%22&limit=1).
Why it’s dangerous
The software may display thumbnails out of order or prevent images from scrolling backward when mammography stacked scrolling is enabled. This could lead to confusion in viewing medical images, but does not pose a direct safety risk to users.
Who’s affected
Medical professionals using Merge OrthoPACS software versions 7.3, 7.3.1, 8.0, and 8.0.1 for mammography imaging are most at risk. The recall affects users who rely on the software's image manipulation tools for viewing and comparing medical images.
How to tell if you have this one
Check if your software version is 7.3, 7.3.1, 8.0, or 8.0.1. The UDI numbers are (01)00842000100706 for 7.3/7.3.1 and (01)00842000100775 for 8.0/8.0.1.
- Brand
Merge Healthcare- Product
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2062-2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1; Version 7.3 (UDI Number (01)00842000100690(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100690(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01) 00842000100737 (10) 8.0.0.162051(11)181026); 8.0.1 (UDI Number (01) 00842000100737(10)8.0.1.165704(11)190528) | 179 devices |
| Z-2063-2019 | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1; 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) | 73 devices |
What to do — step by step
Check Software Version
Verify your OrthoPACS version by checking the software's version number or UDI numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 30 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to do anything?
The recall does not require immediate action, but you should check your software version to ensure you are not using an affected version.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2063-2019 (July 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2063-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.