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Merge Healthcare, Inc.: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Medical DevicesSource: FDA (device) · Date: 2026-09-02

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Merge Healthcare, Inc.
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Reason / hazard
Software issue may cause measurements to be displayed inaccurately.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Recall initiated
2026-07-22
Code info
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Product quantity
20 units
Voluntary mandated
Voluntary: Firm initiated
City
Hartland
State
WI
Country
United States
Event id
99520
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