FDA-Device2016-10-26Class II
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
Sold states
Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
Affected count
844 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2017Don't want to check this manually?
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