Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0118-2017)

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: October 19, 2011

Date Posted: October 26, 2016

Recall Number: Z-0118-2017

Event ID: 75161

Reason for Recall:

Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.

Status: Terminated

Product Quantity: 844 sites potentially have the affected versions

Code Information:

Versions prior to 5.2.6

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated