FDA recall Z-0072-2021

CHANGE HEALTHCARE CANADA COMPANY · Class II · device

Product

Change Healthcare Radiology Solutions 14.0

Reason for recall

Software defect which may potentially result in one or more images missing in a study

Distribution

Domestic distribution to VT, MS, WV, NE

Key facts

Status
Terminated
Initiation date
2020-08-25
Report date
2020-10-14
Termination date
2021-02-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2021