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Merge Healthcare, Inc. recalls Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled March 15, 2017 · FDA recall Z-1403-2017 · Merge Healthcare
Hazard
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. · FDA Class II
Units
110 sites potentially have the affected versions
Sold at
Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
Description
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
Product
Merge Cardio 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 →