Device product
Change Healthcare Radiology Solutions 14.0
Z-0072-2021
Product summary
- Event
- Event 86401
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 devices
- Official record key
device-enforcement:Z-0072-2021
Official wording
Reason: Software defect which may potentially result in one or more images missing in a study
Code information: All Model number 14.0 UDI (01)17540262030020(10)140000
Distribution pattern: Domestic distribution to VT, MS, WV, NE
Derived failure modes
-
Device software or design
Software defect