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Merge Healthcare, Inc. recalls RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled September 21, 2016 · FDA recall Z-2796-2016 · Merge Healthcare
Hazard
Multiple studies were missing at a customer location that never made it to the archive before watermarking · FDA Class II
Units
45 sites potentially have the affected versions
Sold at
Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
Description
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Product
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →