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Merge Healthcare, Inc. recalls Merge RadSuite software. Radiological image processing system.
Recalled September 14, 2016 · FDA recall Z-2715-2016 · Merge Healthcare
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. · FDA Class II
Units
10 sites have the affected software that is configured with the specific conditions listed in Code Information
Sold at
Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Description
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.
Product
Merge RadSuite software. Radiological image processing system.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →