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CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D d
Recalled June 9, 2021 · FDA recall Z-1773-2021 · CHANGE HEALTHCARE CANADA
Hazard
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. · FDA Class II
Units
33 devices
Sold at
US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY.
Description
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Product
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Manufacturer(s)
CHANGE HEALTHCARE CANADA COMPANY
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →