Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1517-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

Product Classification:

Class II

Date Initiated: September 22, 2015

Date Posted: March 29, 2017

Recall Number: Z-1517-2017

Event ID: 76719

Reason for Recall:

Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.

Status: Terminated

Product Quantity: 89 sites potentially have the affected software

Code Information:

Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated