FDA-Device2017-02-15Class II
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Hazard
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Sold states
Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
Affected count
29 sites have the potentially affected software
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge PACS 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-1176-2017Don't want to check this manually?
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