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Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and disp
Recalled August 17, 2016 · FDA recall Z-2363-2016 · Merge Healthcare
Hazard
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same. · FDA Class II
Units
49 sites potentially have the affected versions
Sold at
Worldwide Distribution -- USA and Australia.
Description
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Product
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →