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.
Reported: September 28, 2016 Initiated: November 1, 2012 #Z-2871-2016
Product Description
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.
Reason for Recall
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 1,349 sites potentially have the affected versions
- Distribution
- US Nationwide Distribution
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merge Healthcare, Inc.. Units affected: 1,349 sites potentially have the affected versions.
Why was this product recalled? ▼
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 28, 2016. Severity: Moderate. Recall number: Z-2871-2016.
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