FDA-Device2016-11-23Class II

Merge LIS software.

Merge Healthcare, Inc.
Hazard

There is a potential for duplicate container numbers to be created for patients.

Sold states
Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.
Affected count
413 sites potentially have the affected software
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge LIS software.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2017

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