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Merge Healthcare, Inc. recalls Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled February 15, 2017 · FDA recall Z-1180-2017 · Merge Healthcare
Hazard
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment. · FDA Class II
Units
8 sites have the potentially affected version
Sold at
US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
Description
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Product
Merge RadSuite 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 →