FDA-Device2016-09-07Class II
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Merge Healthcare, Inc.
Hazard
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
Sold states
Nationwide Distribution
Affected count
116 customers potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2709-2016Don't want to check this manually?
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