FDA Recall: Software issue may cause measurements to be displayed inaccurately

Company: Merge Healthcare, Inc.
Date of Enforcement Report: 8/21/2026
Class: II

PRODUCT:

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Recall Number:

Z-3004-2026

REASON:

Software issue may cause measurements to be displayed inaccurately.

RECALLING FIRM/MANUFACTURER:

Merge Healthcare, Inc.

VOLUME:

20 units

DISTRIBUTION:

US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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