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Recall Observatory FDA recall evidence

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

April 19, 2021

Class II

Product summary

Firm
CHANGE HEALTHCARE CANADA COMPANY
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

    reason.device_software_design · v1.0.0

    software defect