Device product
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
Z-0118-2017
Product summary
- Event
- Event 75161
- Status
- Terminated
- Classification
- Class II
- Quantity
- 844 sites potentially have the affected versions
- Official record key
device-enforcement:Z-0118-2017
Official wording
Reason: Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
Code information: Versions prior to 5.2.6
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Device software or design
issue with the software