Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0137-2017)

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. The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: October 26, 2016

Recall Number: Z-0137-2017

Event ID: 75239

Reason for Recall:

The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

Status: Terminated

Product Quantity: 844 sites potentially have the affected versions

Code Information:

Versions prior to 5.2.9

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.

Voluntary or Mandated:

Voluntary: Firm initiated