Device 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.
Z-1773-2021
Product summary
- Event
- Event 87891
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33 devices
- Official record key
device-enforcement:Z-1773-2021
Official wording
Reason: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Code information: Software version 2.0 and 2.1.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
software defect