FDA-Device2016-07-20Class II

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

Merge Healthcare, Inc.
Hazard

Potential data loss occurs as a result of product archiving not working properly.

Sold states
Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
Affected count
49 sites have the affected software
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2016

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