Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1046-2017)

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: March 28, 2016

Date Posted: January 25, 2017

Recall Number: Z-1046-2017

Event ID: 75957

Reason for Recall:

If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.

Status: Terminated

Product Quantity: 188 sites potentially have the effected versions

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, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated