FDA-Device2026-09-02Class IIPROCESSING DEFECT
Merge PACS and OrthoPACS medical imaging software recalled for inaccurate measurement display
What this means
Merge Healthcare's PACS and OrthoPACS medical imaging workstations contain a software issue that may cause measurements to be displayed inaccurately. Version 9.5 is affected. The issue was identified in 20 units distributed across California, Florida, Kentucky, Nebraska, and Washington.
- If you operate or manage affected imaging workstations, contact Merge Healthcare for software correction instructions.
- Do not rely on displayed measurements until the software issue is resolved.
- Check your system version number to confirm whether it matches the affected version (9.5.0).
The agency's original wording
Hazard
Software issue may cause measurements to be displayed inaccurately.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Affected count
20 units
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3004-2026Want us to check the next one for you?
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