FDA recall, , Moderate risk
Merge PACS and Merge OrthoPACS, Medical Imaging Diagnostic Workstation
The medical imaging diagnostic workstation may display measurements inaccurately due to a software issue.
Summary by Recall Canary from the FDA notice
What happened
Merge Healthcare, Inc., of Hartland, Wisconsin, recalled 20 units of its Merge PACS and Merge OrthoPACS medical imaging diagnostic workstations because a software issue may cause measurements to be displayed inaccurately. The company began the recall on July 22, 2026, and the FDA added it to its Enforcement Report on August 21, 2026.
The recall was classified by the FDA on August 21, 2026, and was in the FDA's weekly enforcement report on September 2, 2026. Distribution was US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- UDI-DI
- 00842000101239
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Company
- Merge Healthcare, Inc.Hartland, Wisconsin
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99520
- Recall number
- Z-3004-2026
- Quantity recalled
- 20 units
All recalls from Merge Healthcare, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
