FDA-Device2020-11-04Class II
Merge LIS
Merge Healthcare, Inc.
Hazard
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
Sold states
Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.
Affected count
47 units
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge LIS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2021Don't want to check this manually?
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