Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0730-2017)

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:

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems 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: October 1, 2015
Date Posted: December 21, 2016
Recall Number: Z-0730-2017
Event ID: 75714
Reason for Recall:

Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.

Status: Terminated
Product Quantity: 116 sites potentially have the effected versions
Code Information:

Versions V10.1 and 10.1.1

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated