Recall Z-2871-2016— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2012-11-01, terminated 2020-10-05. It names one FDA 510(k) clearance: K092954. 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.. Reason: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-01
- Terminated
- 2020-10-05
- Firm location
- Hartland, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.