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Recall Observatory FDA recall evidence

Device product

Change Healthcare Enterprise Viewer

Z-1508-2021

March 17, 2021

Class II

Product summary

Firm
CHANGE HEALTHCARE CANADA COMPANY
Event
Event 87616
Status
Ongoing
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-1508-2021

Official wording

Reason: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

Code information: Change Healthcare Enterprise Viewer 2.0 and 2.1

Distribution pattern: Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software defect