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Merge Healthcare, Inc. recalls CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled October 26, 2016 · FDA recall Z-0137-2017 · Merge Healthcare
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. · FDA Class II
Units
844 sites potentially have the affected versions
Sold at
Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
Description
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.
Product
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →