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Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled February 15, 2017 · FDA recall Z-1176-2017 · Merge Healthcare
Hazard
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. · FDA Class II
Units
29 sites have the potentially affected software
Sold at
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.
Description
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Product
Merge PACS 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 →