FDA-Device2021-06-09Class II
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.
CHANGE HEALTHCARE CANADA COMPANY
Hazard
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Sold states
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.
Affected count
33 devices
Manufactured in
10711 Cambie Rd Suite 130, Richmond, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2021Don't want to check this manually?
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