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