FDA recall Z-1508-2021

CHANGE HEALTHCARE CANADA COMPANY · Class II · device

Product

Change Healthcare Enterprise Viewer

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2021-03-17
Report date
2021-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1508-2021