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.
FDA Recall Z-2871-2016 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-11-01
Date Terminated2020-10-05
Product Quantity1,349 sites potentially have the affected versions
Reason for Recall
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
Firm Action
Merge sent Urgent Medical Device Recall dated January 28, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions Merge Customer Service at (877) 741-5369 or [email protected].
Root Cause
Error in labeling
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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