← FDA ENFORCEMENT
Z-3004-2026Class II
Merge Healthcare, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Merge Healthcare, Inc.
Product type
Device
Status
Ongoing
Report date
2026-09-02
Distribution
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Firm state
WI
Product quantity
20 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Software issue may cause measurements to be displayed inaccurately.
Product description
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Code / lot info
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →