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Merge Healthcare, Inc. recalls Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled December 28, 2016 · FDA recall Z-0878-2017 · Merge Healthcare
Hazard
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment. · FDA Class II
Units
30 sites potentially have the effected versions
Sold at
Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.
Description
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
Product
Merge OrthoCase 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 →