Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2871-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 1, 2012

Date Posted: September 28, 2016

Recall Number: Z-2871-2016

Event ID: 75158

Reason for Recall:

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

Status: Terminated

Product Quantity: 1,349 sites potentially have the affected versions

Code Information:

All versions - Versions 4.1.3 and prior versions

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated