FDA-Device2016-12-28Class II
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
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.
Sold states
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.
Affected count
30 sites potentially have the effected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0878-2017Don't want to check this manually?
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