FDA-Device2016-09-14Class II
Merge RadSuite software. Radiological image processing system.
Merge Healthcare, Inc.
Hazard
When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
Sold states
Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Affected count
10 sites have the affected software that is configured with the specific conditions listed in Code Information
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge RadSuite software. Radiological image processing system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2715-2016Don't want to check this manually?
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