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-2871-2016
Product summary
- Event
- Event 75158
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,349 sites potentially have the affected versions
- Official record key
device-enforcement:Z-2871-2016
Official wording
Reason: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Code information: All versions - Versions 4.1.3 and prior versions
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.