FDA recall Z-3004-2026

Merge Healthcare, Inc. · Class II · device

Product

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Reason for recall

Software issue may cause measurements to be displayed inaccurately.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2026-07-22
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3004-2026